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Medication Alerts

November 18, 2013
Urgent Product Recall - Freestyle® and Freestyle Lite® Test Strips
On November 18, 2013, Abbott Diabetes Care (ADC) issued a voluntary product recall on 20 lots of FreeStyle® and FreeStyle Lite® Blood Glucose Test Strips. The affected FreeStyle®... [more]

October 24, 2013
New Oklahoma Hydrocodone Law
Effective November 1, 2013, written or oral prescriptions for any medication containing hydrocodone may not be refilled by Oklahoma pharmacies. This applies even if the prescription... [more]

July 31, 2013
FDA announces a voluntary recall of Nova Max Blood Glucose Test Strips
July 31, 2013
The U.S. Food and Drug Administration is working with Nova Diabetes Care to recall 21 lots of glucose test strips marketed under the brand names Nova... [more]

April 15, 2013
Abbott Initiates Voluntary Recall of FreeStyle lnsulinx® Blood Glucose Meters in the United States
On Apri1 15, 2013 - Abbott announced it is initiating a voluntary recall of FreeStyle lnsulinx® Blood Glucose Meters in the United States.
The company has determined that... [more]

December 07, 2012
Recall: Qualitest Hydrocodone Bitartrate and Acetaminophen Tablets 10 mg/500 mg - Potential for Oversized Tablets
Qualitest, a subsidiary of Endo Health Solutions, issued a voluntary nationwide recall for 101 lots of Hydrocodone Bitartrate and Acetaminophen 10 mg/500 mg tablets, which are... [more]

November 26, 2012
Atorvastatin Recall – Ranbaxy Pharmaceuticals Inc.
Ranbaxy Pharmaceuticals Inc. is conducting a voluntary recall at the retail level for select batches and strengths of atorvastatin calcium (generic Lipitor) tablets that may contain... [more]

May 07, 2012
FDA Drug Safety Communication: Safety Review Update of Cancer Drug Revlimid (Lenalidomide) and Risk of Developing New Types of Malignancies.
The U.S. Food and Drug Administration (FDA) is informing the public of an increased risk of second primary malignancies (new types of cancer) in patients with newly-diagnosed multiple... [more]

April 26, 2012
FDA Drug Safety Communication: Updated Information on Drug Interactions between Victrelis (Boceprevir) and Certain Boosted HIV Protease Inhibitor Drugs
The U.S. Food and Drug Administration (FDA) is notifying the public that co-administration of Victrelis (boceprevir), a hepatitis C virus (HCV) protease inhibitor, along with certain... [more]

April 20, 2012
FDA Drug Safety Communication: New Warning and Contraindication for Blood Pressure Medicines Containing Aliskiren (Tekturna).
The U.S. Food and Drug Administration (FDA) is warning of possible risks when using blood pressure medicines containing aliskiren with other drugs called angiotensin converting... [more]

April 10, 2012
FDA Drug Safety Communication: Updated Information About the Risk Of Blood Clots in Women Taking Birth Control Pills Containing Drospirenone.
The U.S. Food and Drug Administration (FDA) has completed its review of recent observational (epidemiologic) studies regarding the risk of blood clots in women taking drospirenone-containing... [more]

March 28, 2012
FDA Drug Safety Communication: Revised Recommendations for Celexa (Citalopram Hydrobromide) Related to a Potential Risk of Abnormal Heart Rhythms with High Doses.
This update provides additional information related to a previous FDA Drug Safety Communication (posted 8/24/2011): Abnormal heart rhythms associated with high doses of Celexa... [more]

March 01, 2012
FDA Drug Safety Communication: Interactions between Certain HIV or Hepatitis C Drugs and Cholesterol-Lowering Statin Drugs Can Increase the Risk of Muscle Injury
The U.S. Food and Drug Administration (FDA) is issuing updated recommendations concerning drug-drug interactions between drugs for human immunodeficiency virus (HIV) or hepatitis... [more]

February 28, 2012
FDA Drug Safety Communication: Important Safety Label Changes to Cholesterol-Lowering Statin Drugs.
The U.S. Food and Drug Administration (FDA) has approved important safety label changes for the class of cholesterol-lowering drugs known as statins.
Statins are prescription... [more]

February 27, 2012
Norgestimate and Ethinyl Estradiol Tablets: Recall - Packaging Error, Potential for Incorrect Dosing Regimen
Glenmark Generics Inc. issued a nationwide, consumer-level recall of seven (7) lots of Norgestimate and Ethinyl Estradiol Tablets USP (0.18 mg/0.035 mg, 0.215 mg/0.035 mg, 0.25... [more]

February 22, 2012
Healthy People Co. Dietary Supplements: Recall - Undeclared Drug Ingredient
Healthy People Co. notified the public that it is expanding its nationwide recall of the company’s dietary supplements, sold under the brand names Healthy People Co., regardless... [more]

February 17, 2012
Infants’ TYLENOL Oral Suspension, 1 oz. Grape: Recall - Dosing System Complaints
McNeil Consumer Healthcare notified the public of a recall of seven lots (approximately 574,000 bottles) of Infants’ TYLENOL Oral Suspension, 1 oz. Grape. There were complaints... [more]

February 08, 2012
FDA Drug Safety Communication: Clostridium Difficile-Associated Diarrhea Can Be Associated with Stomach Acid Drugs Known as Proton Pump Inhibitors (PPIs).
The U.S. Food and Drug Administration (FDA) is informing the public that the use of stomach acid drugs known as proton pump inhibitors (PPIs) may be associated with an increased... [more]

February 08, 2012
FDA Drug Safety Communication: Important Drug Interactions Between Victrelis (Boceprevir) and Ritonavir-Boosted Human Immunodeficiency Virus (HIV) Protease Inhibitor Drugs.
The U.S. Food and Drug Administration (FDA) is notifying healthcare professionals and patients that drug interactions between the hepatitis C virus (HCV) protease inhibitor Victrelis... [more]

February 01, 2012
Pfizer Announces Voluntary Nationwide Recall Of Lo/Ovral®-28 and Norgestrel/Ethinyl Estradiol Tablets Due To Possibility of Inexact Tablet Counts Or Out Of Sequence Tablets
Pfizer Inc. announced that it has voluntarily recalled 14 lots of Lo/Ovral®-28 (norgestrel and ethinyl estradiol)Tablets and 14 lots of Norgestrel and Ethinyl Estradiol Tablets... [more]

January 12, 2012
Potential Risks of Cardiovascular and Renal Adverse Events in Patients with Type 2 Diabetes and Renal Impairment and/or Cardiovascular Disease Treated with Aliskiren (Tekturna®) and Aliskiren-Containing Combination Products.
Novartis recently announced new safety information for aliskiren (Tekturna®) following interim results from the Aliskiren Trial in Type 2 Diabetes Using Cardio-Renal Endpoints... [more]

January 09, 2012
Endo Pharmaceuticals Opiate Products by Novartis Consumer Health: Public Health Advisory - Potential Safety Risk
The FDA is advising the public of a potential problem with opiate products manufactured and packaged for Endo Pharmaceuticals by Novartis Consumer Health at its Lincoln, Nebraska... [more]

January 08, 2012
Novartis Consumer Health Inc. Issues Voluntary Nationwide Recall Of Certain Over-The-Counter Products Due to Potential Presence of Foreign Tablets or Chipped or Broken Tablets or Gelcaps.
Novartis Consumer Health, Inc. (NCH) announced that it is voluntarily recalling all lots of select bottle packaging configurations of Excedrin® and NoDoz® products with expiry... [more]

December 22, 2011
Drug Safety Communication: Liquid Acetaminophen marketed for infants - Potential for Dosing Errors
The FDA is informing the public that an additional concentration of liquid acetaminophen marketed for “infants” (160 mg/5 mL) is now available. This change in the concentration... [more]

December 15, 2011
FDA Drug Safety Communication: Revised Dose Limitation For Zocor (Simvastatin) When Taken with Amiodarone
The U.S. Food and Drug Administration (FDA) is notifying the public that it has revised the dose limitation for the cholesterol-lowering drug simvastatin from 10 mg to 20 mg when... [more]

December 14, 2011
FDA Drug Safety Communication: Selective Serotonin Reuptake Inhibitor (SSRI) Antidepressant Use During Pregnancy and Reports of a Rare Heart and Lung Condition in Newborn Babies
The U.S. Food and Drug Administration (FDA) is updating the public on the use of selective serotonin reuptake inhibitor (SSRI) antidepressants by women during pregnancy and the... [more]

December 07, 2011
FDA Drug Safety Communication: Safety Review of Post-Market Reports of Serious Bleeding Events with the Anticoagulant Pradaxa (Dabigatran Etexilate Mesylate)
The U.S. Food and Drug Administration (FDA) is evaluating post-marketing reports of serious bleeding events in patients taking Pradaxa (dabigatran etexilate mesylate). Pradaxa... [more]

November 09, 2011
FDA Drug Safety Communication: Review update of Trilipix (fenofibric acid) and the ACCORD Lipid trial
The U.S. Food and Drug Administration (FDA) is informing the public that the cholesterol-lowering medicine Trilipix (fenofibric acid) may not lower a patient's risk of having a... [more]

November 01, 2011
FDA Drug Safety Communication: Safety Review Update of Medications used to treat Attention-Deficit/Hyperactivity Disorder (ADHD) in children and young adults
Safety Announcement
The FDA is updating the public about the ongoing safety review of stimulant medications used in children with Attention-Deficit/Hyperactivity... [more]

October 25, 2011
FDA Drug Safety Communication: Voluntary market withdrawal of Xigris [activated drotrecogin alfa) due to failure to show a survival benefit.
The FDA is informing healthcare professionals and the public that on October 25, 2011, Eli Lilly and Company announced a worldwide voluntary market withdrawal of Xigris (activated... [more]

October 20, 2011
Rosiglitazone Risk Evaluation and Mitigating Strategy (REMS) Program to Restrict Access to Rosiglitazone-Containing Medicine: Avandia, Avandamet, and Avandaryl
Effective November 18, 2011, rosiglitazone-containing medicines (Avandia, Avandamet, and Avandaryl), used to treat type II diabetes, will no longer be available through retail... [more]

October 11, 2011
Drug Safety Communication: Sprycel (dasatinib) - Risk of Pulmonary Arterial Hypertension
The FDA is warning the public that the leukemia drug Sprycel (dasatinib), may increase the risk of pulmonary arterial hypertension (PAH), a rare, but serious condition in which... [more]

October 06, 2011
FDA Approves Cialis to Treat Benign Prostatic Hyperplasia
The U.S. Food and Drug Administration approved Cialis (tadalafil) to treat the signs and symptoms of benign prostatic hyperplasia (BPH), a condition in which the prostate gland... [more]

September 16, 2011
Qualitest Pharmaceuticals Oral Contraceptives:
Qualitest Pharmaceuticals issued a nationwide, retail-level recall of multiple lots of oral contraceptives because a packaging error may result in the daily regimen for these products... [more]

September 15, 2011
FDA Drug Safety Communication: Abnormal heart rhythms may be associated with use of Zofran (ondansetron).
The U.S. Food and Drug Administration (FDA) is informing the public of an ongoing safety review of the Zofran (ondansetron), a drug used to prevent nausea and vomiting caused by... [more]

September 07, 2011
FDA Drug Safety Communication: Drug labels for the Tumor Necrosis Factor-alpha (TNFa) blockers now include warnings about infection with Legionella and Listeria bacteria.
The U.S. Food and Drug Administration (FDA) is informing healthcare professionals that the Boxed Warning for the entire class of Tumor Necrosis Factor-alpha (TNFa) blockers has... [more]

September 01, 2011
FDA Drug Safety Communication: Serious allergic reactions reported with the use of Saphris (asenapine maleate).
The U.S. Food and Drug Administration (FDA) is warning the public that serious allergic reactions have been reported with the use of Saphris (asenapine maleate), an antipsychotic... [more]

September 01, 2011
FDA Drug Safety Communication: New contraindication and updated warning on kidney impairment for Reclast (zoledronic acid).
FDA Drug Safety Communication: New contraindication and updated warning on kidney impairment for Reclast (zoledronic acid).
The revised drug label will enhance the safe... [more]

August 24, 2011
Drug Safety Communication: Abnormal Heart Rhythms Associated With High Doses of Celexa (citalopram hydrobromide).
FDA notified healthcare professionals and patients that the antidepressant Celexa (citalopram hydrobromide) should no longer be used at doses greater than 40 mg per day because... [more]

August 03, 2011
Drug Safety Communication: Long-Term, High-Dose Use of Diflucan (fluconazole) During Pregnancy May Be Associated With Birth Defects.
FDA is informing the public that treatment with chronic, high doses (400-800mg/day) of Diflucan (fluconazole) during the first trimester of pregnancy may be associated with a rare... [more]

July 26, 2011
FDA Drug Safety Communication: Serious CNS reactions possible when linezolid (Zyvox®) or methylene blue is given to patients taking certain psychiatric medications.
FDA has received reports of serious central nervous system (CNS) reactions when linezolid (marketed as Zyvox®) or methylene blue is given to patients taking psychiatric medications... [more]

July 21, 2011
FDA Drug Safety Communication: Multaq (dronedarone) and increased risk of death and serious cardiovascular adverse events.
FDA is reviewing data from a clinical trial that was evaluating the effects of the antiarrhythmic drug Multaq (dronedarone) in patients with permanent atrial fibrillation.... [more]

July 21, 2011
FDA Drug Safety Communication: Ongoing safety review of oral bisphosphonates and potential increased risk of esophageal cancer.
FDA announced its ongoing review of data from published studies to evaluate whether the use of oral bisphosphonates, drugs commonly used for the prevention and treatment of bone... [more]

July 14, 2011
FDA Drug Safety Communication: Chantix (varenicline) may increase the risk of certain cardiovascular adverse events in patients with cardiovascular disease
The U.S. Food and Drug Administration (FDA) notified the public that the smoking cessation aid Chantix (varenicline) may be associated with a small, increased risk of certain cardiovascular... [more]

July 14, 2011
FDA Drug Safety Communication: Update to ongoing safety review of Actos (pioglitazone) and increased risk of bladder cancer
FDA informed the public that use of the diabetes medication Actos (pioglitazone) for more than one year may be associated with an increased risk of bladder cancer. Information... [more]

July 14, 2011
FDA Drug Safety Communication: Medication errors resulting from confusion between risperidone (Risperdal) and ropinirole (Requip)
The FDA alerted the public to medication error reports in which patients were given risperidone (Risperdal) instead of ropinirole (Requip) and vice versa. In some cases, patients... [more]

July 14, 2011
FDA Drug Safety Communication: 5-alpha reductase inhibitors (5-ARIs) may increase the risk of a more serious form of prostate cancer
The FDA informed healthcare professionals that the Warnings and Precautions section of the labels for the 5-alpha reductase inhibitor (5-ARI) class of drugs has been revised... [more]

June 27, 2011
Stolen Abbott Diabetes Care Blood Glucose Monitoring Products
One tractor-trailer shipment of Abbot Diabetes Care blood glucose monitoring products was recently reported stolen from a shipping carrier facility in Louisville, KY. Abbot Diabetes... [more]

June 08, 2011
FDA Drug Safety Communication: New Restrictions, Contraindications, and Dose Limitations for Zocor (simvastatin) to Reduce the Risk of Muscle Injury
Summary:
The U.S. Food and Drug Administration (FDA) is recommending limiting the use of the highest approved dose of the cholesterol-lowering medication, simvastatin... [more]

January 20, 2011
The following drug is experiencing a shortage:
Company: Genentech - Product support and fulfillment: 800-551-2231, for medical information: 800-821-8590
Reason for shortage: Increased demand
Related Information:... [more]

January 14, 2011
Multaq (dronedarone) - Drug Safety Communication: Risk of Severe Liver Injury
ISSUE: FDA notified healthcare professionals and patients about cases of rare, but severe liver injury, including two cases of acute liver failure leading to liver transplant... [more]

January 14, 2011
Drug Shortages:
BICNU
Drug Shortage: BICNU (carmustine) Injection, Bristol-Myers Squibb (100 mg, NDC 00015-3012-60)
Company: Bristol-Myers Squibb 1-800-332-2056
Reason for... [more]

January 11, 2011
Morphine Sulfate Oral Solution 100 mg per 5 mL (20 mg/mL): Medication Use Error - Reports of Accidental Overdose
Roxane Laboratories and FDA notified healthcare professionals of serious adverse events and deaths resulting from accidental overdose of morphine sulfate oral solutions, especially... [more]

January 05, 2011
Albuterol Sulfate Inhalation Solution 0.083%, 3 mL Unit Dose Vials: Recall - Mislabeled Unit Dose Vials
The Ritedose Corporation is conducting a voluntary recall of 0.083% Albuterol Sulfate Inhalation Solution, 3 mL in 25, 30, and 60 unit dose vials. This product is being recalled... [more]

December 29, 2010
Acetadote (acetylcysteine) Injection: Recall - Particulate Matter Found in a Small Number of Vials
Cumberland Pharmaceuticals Inc. recalled 6 lots of Acetadote (acetylcysteine) Injection, 20% solution (200mg/mL) in 30 mL single dose glass vials as a precautionary measure based... [more]

December 29, 2010
Dexamethasone Sodium Phosphate Injection, 4 mg/mL, 30 mL Multiple Dose Vial: Recall due to Particulates in Product
American Regent and FDA notified healthcare professionals of the nationwide recall of specific lots of Dexamethasone Sodium Phosphate Injection, USP 4 mg/mL, 30 mL Multiple Dose... [more]

December 22, 2010
Abbott Glucose Test Strips: Recall - False Low Blood Glucose Results
ISSUE: FDA and Abbott Diabetes Care notified healthcare professionals and patients of a recall of 359 different lots of glucose test strips marketed under the following... [more]

December 16, 2010
Avastin (bevacizumab): Process for Removal of Breast Cancer Indication Begun
ISSUE: FDA notified healthcare professionals and patients that it is recommending removing the breast cancer indication for Avastin (bevacizumab) because the drug has not... [more]

December 14, 2010
Tessalon (benzonatate): Drug Safety Communication - Potential for Accidental Ingestion by Children
FDA is warning the public that accidental ingestion of benzonatate by children under the age of 10 years can result in death from overdose. Overdose with benzonatate in children... [more]

December 13, 2010
Reese Pharmaceutical Company OTC Products: Recall - Mislabeled Guaifenesin Tablets
Reese Pharmaceutical Company has voluntarily recalled lot# 091612 only in 60-count size bottles identified under four different brand names: Refenesen Expectorant (guaifenesin... [more]

November 19, 2010
Voluntary Withdrawal of Propoxyphene Products
Propoxyphene is an opioid medication that was first approved by FDA in 1957. It has been marketed in the United States since 1976 as a Schedule IV Controlled Substances used as... [more]

November 01, 2010
Lipitor Recall Information
Public Notice:
Pfizer recalled specific bottles of LIPITOR (40 mg only) due to a small number of reports of an uncharacteristic odor related to the bottles in which... [more]

October 25, 2010
Actavis Inc. Issues a Voluntary Recall of 18 Lots of Fentanyl Transdermal System 25 mcg/h
Actavis Inc. today announced a voluntary recall to the wholesale and retail levels only of 18 lots of Fentanyl Transdermal System 25 mcg/hour C-II patches manufactured for Actavis... [more]

October 19, 2010
Tylenol 8 Hour Caplets 50 Count: Recall
AUDIENCE: Consumer, Pharmacy
ISSUE: McNeil is recalling TYLENOL 8 Hour caplets 50 count bottles to the retail level following a small number of complaints... [more]

October 18, 2010
Shortage: Adriamycin
The following drug is experiencing a shortage:
Drug Shortage: Adriamycin (doxorubicin) lyophilized powder
Company: Bedford Customer service - 800-562-4797
Reason... [more]

October 15, 2010
Drug Shortage: Glucagon 1mg emergency kit, GlucaGen 1mg Hypokit, GlucaGen 1mg Vials
The following drug is experiencing a shortage:

Drug Shortage: Glucagon 1mg emergency kit, GlucaGen 1mg Hypokit, GlucaGen 1mg Vials

Company:
Eli Lilly: 800-545-5979
Novo... [more]

October 08, 2010
Meridia (sibutramine): Market Withdrawal Due to Risk of Serious Cardiovascular Events
ISSUE: Abbott Laboratories and FDA notified healthcare professionals and patients about the voluntary withdraw of Meridia (sibutramine), an obesity drug, from the U.S. market... [more]

October 08, 2010
Stalevo(carbidopa/levodopa and entacapone): Ongoing Safety Review: Possible increased cardiovascular risk
ISSUE: FDA notified healthcare professionals that it is evaluating clinical trial data that suggest patients taking Stalevo (a combination of carbidopa/levodopa and entacapone)... [more]

September 28, 2010
Amgen Initiates Voluntary Nationwide Recall of Certain Lots Of Epogen® And Procrit® (Epoetin Alfa)
Amgen Initiates Voluntary Nationwide Recall of Certain Lots Of Epogen® And Procrit® (Epoetin Alfa)
Evaluations by Amgen and Centocor Ortho Biotech Products, L.P. found a... [more]

September 20, 2010
Pediatric Group Issues New Flu Shot Guidelines
All children and adolescents 6 months of age and older should receive the annual trivalent influenza vaccine this flu season, according to updated recommendations from the American... [more]

August 16, 2010
Midodrine hydrochloride: FDA Proposes Withdrawal of Low Blood Pressure Drug
ISSUE: FDA proposed to withdraw approval of the drug midodrine hydrochloride, used to treat the low blood pressure condition, orthostatic hypotension, because required post-approval... [more]

August 12, 2010
FDA Drug Safety Communication: Aseptic meningitis associated with use of Lamictal (lamotrigine)
The U.S. Food and Drug Administration (FDA) is informing the public that Lamictal (lamotrigine)†, a medication commonly used for seizures in children two years and older, and bipolar... [more]

July 29, 2010
Cubicin (daptomycin): Drug Safety Communication - Risk of Eosinophilic Pneumonia
ISSUE: FDA notified healthcare professionals and patients about the potential for developing eosinophilic pneumonia during treatment with Cubicin (daptomycin), an intravenous... [more]

July 13, 2010
Arava (leflunomide): Boxed Warning - Risk of Severe Liver Injury
ISSUE: FDA is adding information on severe liver injury to the Boxed Warning of Arava (leflunomide) a drug used to treat rheumatoid arthritis - to highlight the risk of... [more]

July 12, 2010
Bristol-Myers Squibb Initiates a Nationwide Voluntary Recall of Coumadin® 1 mg Tablet Blister Packs
Bristol-Myers Squibb initiates a voluntary recall of 3 lots of physician sample blister packs of Coumadin® 1 mg tablets and 5 lots, of Coumadin 1 mg tablet hospital unit dose (HUD)... [more]

July 08, 2010
McNeil Consumer Healthcare Announces Voluntary Recall of Certain Over-The-Counter (OTC) Products in the United States, Fiji, Guatemala, Dominican Republic, Puerto Rico, Trinidad & Tobago, and Jamaica
McNeil Consumer Healthcare, Division of McNEIL-PPC, Inc., is recalling 21 lots of over-the-counter medicines. The lots involved, listed below, are sold in the United States, Fiji,... [more]

July 08, 2010
Qualaquin (quinine sulfate): New Risk Evaluation and Mitigation Strategy - Risk of serious hematological reactions
ISSUE: Due to continued reports of serious side effects in patients using Qualaquin "off-label" for night time leg cramps, FDA has approved a risk management plan to warn... [more]

June 28, 2010
EPINEPHrine pre-filled syringe shortage
EPINEPHrine emergency syringes 1 mg/10 mL (0.1 mg/mL) are currently on backorder from the sole manufacturer of this product. Although the shortage is expected to resolve later... [more]

June 15, 2010
Mcneil Consumer Healthcare Recalls Four Product Lots of Benadryl® Allergy Ultratab™ Tablets, 100 Count, and One Product Lot of Extra Strength Tylenol® Rapid Release Gels, 50 Count
McNeil Consumer Healthcare, Division of McNEIL-PPC, Inc., is recalling five product lots as an addition to the list of products included in the company’s January 15th, 2010 product... [more]

June 11, 2010
Benicar (olmesartan): Ongoing Safety Review
The U.S. Food and Drug Administration is looking into whether Daiichi Sankyo's <4568.T> blood pressure medicine Benicar increases the risk of heart-related death, although the... [more]

June 11, 2010
Claris Lifesciences initiates a nationwide voluntary recall of all lots of Ciprofloxacin Inj. USP 200 mg / 100 mL, Ciprofloxacin Inj. USP 400 mg / 200 mL, Metronidazole Inj. USP 500 mg/100 ml and Ondansetron Inj., 32 mg / 50 mL.
Claris Lifesciences today announces the voluntary nationwide recall of all lots of Ciprofloxacin Inj. USP 200 mg / 100 mL (NDC 36000-008-24), Ciprofloxacin Inj. USP 400 mg / 200... [more]

May 25, 2010
Ultram (tramadol hydrochloride), Ultracet (tramadol hydrochloride/acetaminophen): Label Change
Ortho-McNeil-Janssen and FDA notified healthcare professionals of changes to the Warnings section of the prescribing information for Tramadol, a centrally acting synthetic opioid... [more]

May 25, 2010
Proton Pump Inhibitors (PPI): Class Labeling Change
FDA notified healthcare professionals and patients of revisions to the prescription and over-the-counter [OTC] labels for proton pump inhibitors, which work by reducing the amount... [more]

May 17, 2010
Sagent Pharmaceuticals Initiates a Nationwide Voluntary Recall of All Lots of Metronidazole Injection, USP 500 mg/100 mL
Sagent Pharmaceuticals, Inc. announced the voluntary nationwide recall of all lots of metronidazole injection, USP 500mg / 100mL (NDC number 25021-131-82) manufactured by Claris... [more]

May 03, 2010
Recall: McNeil Children's OTC
McNeil Consumer Healthcare and FDA notified healthcare professionals of a voluntary recall of certain over-the-counter (OTC) Children's and Infants' liquid products manufactured... [more]

March 20, 2010
FDA Warns about Increased Risk of Muscle Injury with Zocor
The U.S. Food and Drug Administration today warned patients and healthcare providers about the potential for increased risk of muscle injury from the cholesterol-lowering medication... [more]

March 12, 2010
Information on Clopidogrel Bisulfate (marketed as Plavix)
The U.S. Food and Drug Administration (FDA) has added a Boxed Warning to the label for Plavix, the anti-blood clotting medication. The Boxed Warning is about patients... [more]

February 26, 2010
OneTouch SureStep Test Strips (LifeScan): Recall
LifeScan and FDA notified healthcare professionals of a voluntary recall of eight lots of OneTouch SureStep Test Strips, used by people with diabetes to measure their blood glucose... [more]

February 23, 2010
Invirase (saquinavir): Ongoing safety review of clinical trial data
FDA notified healthcare professionals and patients that it is reviewing clinical trial data about a potentially serious effect on the heart from the use of Invirase (saquinavir)... [more]

February 22, 2010
Avandia (rosiglitazone): Ongoing Review of Cardiovascular Safety
FDA notified healthcare professional and patients that it is reviewing the primary data from a large, long-term clinical study, RECORD, on possible cardiovascular risks with the... [more]

February 18, 2010
Long-Acting Beta-Agonists (LABAs): New Safe Use Requirements
FDA notified healthcare professionals and consumers that, due to safety concerns, FDA is requiring a risk management strategy (REMS) and class-labeling changes for all LABAs. The... [more]

February 17, 2010
Maalox Total Relief and Maalox Liquid Products: Medication Use Errors
FDA notified consumers and healthcare professionals about reports of serious medication errors involving consumers who used Maalox Total Relief when they had intended to use a... [more]

December 30, 2009
Mcneil Consumer Healthcare Announces A Voluntary Nationwide Recall Of All Lots Of Tylenol® Arthritis Pain 100 Count With Ez-Open Cap
In consultation with the U.S. Food and Drug Administration (FDA), McNeil Consumer Healthcare, Division of McNEIL-PPC, Inc., is expanding its voluntary recall to include all available... [more]

December 10, 2009
FDA MedWatch - Alka-Seltzer Plus Day & Night Cold Formula Liquid Gels - Incorrect Packaging
Bayer Consumer Care and FDA notified Consumers of a recall of a single product lot of the combination package of Alka-Seltzer Plus Day & Night Cold Formula Liquid Gels. The labeling... [more]

December 04, 2009
Information for Healthcare Professionals: Risk of Neural Tube Birth Defects following prenatal exposure to Valproate
The FDA is reminding health care professionals about the increased risk of neural tube defects and other major birth defects, such as craniofacial defects and cardiovascular malformations,... [more]

November 23, 2009
Early Communication about an Ongoing Safety Review of Meridia (sibutramine hydrochloride)
FDA is reviewing preliminary data from a recent study suggesting that patients using sibutramine have a higher number of cardiovascular events (heart attack, stroke, resuscitated... [more]

October 12, 2009
Relenza (zanamivir) Inhalation Powder
GlaxoSmithKline (GSK) and FDA notified healthcare professionals of a report of the death of a patient with influenza who received Relenza (zanamivir) Inhalation Powder which was... [more]

September 28, 2009
Sitagliptin (marketed as Januvia and Janumet) - acute pancreatitis
FDA notified healthcare professionals and patients of revisions to the prescribing information for Januvia (sitagliptin) and Janumet (sitagliptin/metformin) to include information... [more]

September 28, 2009
Exjade (deferasirox) - Early Communication
FDA notified healthcare professionals of an Early Communication regarding an ongoing review of safety issues with Exjade (deferasirox). New safety data suggests there may be a... [more]

September 28, 2009
FDA Informs Consumers of a Nationwide Voluntary Recall of Certain Tylenol Products
The U. S. Food and Drug Administration wants to make consumers aware of a voluntary recall conducted by McNeil Consumer Healthcare of certain lots of oral suspension Children's... [more]

September 15, 2009
FDA Approves Vaccines for 2009 H1N1 Influenza Virus
The U.S. Food and Drug Administration announced today that it has approved four vaccines against the 2009 H1N1 influenza virus. The vaccines will be distributed nationally after... [more]

August 25, 2009
Early Communication about an Ongoing Safety Review Orlistat (marketed as Alli and Xenical)
FDA is reviewing new safety information regarding reports of liver-related adverse events in patients taking orlistat. Orlistat is marketed in the United States as a prescription... [more]

August 17, 2009
Barr Laboratories, Inc. issues a voluntary nationwide recall of Dextroamphetamine/Amphetamine 20mg Tablets, Lot number 311756
Barr Laboratories, Inc. is initiating a voluntary recall of Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate (Mixed Salts... [more]

August 03, 2009
FDA Updates Warnings for TNF Blockers and Cancer Risk
The US Food and Drug Administration (FDA) is requiring stronger warnings regarding the risk for cancer associated with tumor necrosis factor (TNF) blockers.
An alert sent... [more]

July 17, 2009
Propofol Recall
Teva Pharmaceuticals USA is initiating a voluntary recall of Propofol Injectable Emulsion 10 mg/mL 100 mL vials, lot numbers 31305429B and 31305430B. The product lots identified... [more]

July 14, 2009
Immunosuppressant Drugs: Required Labeling Changes
The U.S. Food and Drug Administration (FDA) is requiring the makers of certain immunosuppressant drugs to update their labeling to reflect that immunosuppressed patients are at... [more]

July 09, 2009
FDA Takes Actions on Darvon, Other Pain Medications Containing Propoxyphene
The U.S. Food and Drug Administration is taking several actions to reduce the risk of overdose in patients using pain medications such as Darvon and Darvocet that contain propoxyphene.... [more]

July 02, 2009
Important information related to the safe use of acetaminophen:
Dear Colleagues:
Yesterday, an advisory committee convened by the U.S. Food and Drug Administration (FDA) provided feedback on options proposed by FDA to reduce liver... [more]

July 01, 2009
Varenicline (marketed as Chantix) and Bupropion (marketed as Zyban, Wellbutrin, and generics)
FDA notified healthcare professionals and patients that it has required the manufacturers of the smoking cessation aids varenicline (Chantix) and bupropion (Zyban and generics)... [more]

July 01, 2009
Lantus (insulin glargine)
FDA notified healthcare professionals and patients that it is aware of four recently-published observational studies that looked at the use of Lantus (insulin glargine) and possible... [more]

June 16, 2009
Zicam Cold Remedy Nasal Products (Cold Remedy Nasal Gel, Cold Remedy Nasal Swabs, and Cold Remedy Swabs, Kids Size)
FDA notified consumers and healthcare professionals to discontinue use of three Zicam Nasal Gel/Nasal Swab products sold over-the-counter as cold remedies because they are associated... [more]

June 15, 2009
FDA Issues Public Health Advisory Regarding Levemir Insulin
The U.S. Food and Drug Administration has learned that some stolen vials of the long-acting insulin Levemir made by Novo Nordisk Inc. have reappeared and are being sold in the... [more]

June 11, 2009
Sirolimus (marketed as Rapamune)
FDA notified healthcare professionals of clinical trial data that suggest increased mortality in stable liver transplant patients after conversion from a calcineurin inhibitor... [more]

June 08, 2009
FDA Warns About Serious Liver Injury Associated With Anti-Thyroid Drug
The U.S. Food and Drug Administration today warned health care professionals about the risk of serious liver injury associated with the use of the anti-thyroid drug propylthiouracil... [more]

May 01, 2009
FDA Warns Consumers to Stop Using Hydroxycut Products
The U.S. Food and Drug Administration is warning consumers to immediately stop using Hydroxycut products by Iovate Health Sciences Inc., of Oakville, Ontario and distributed by... [more]

April 26, 2009
US Declares Swine Flu Emergency
The U.S. government today declared the swine flu outbreak a public health emergency. Swine flu has sickened at least 20 people in the U.S., by the CDC's latest count.
As... [more]

April 21, 2009
Swine Flu FAQ
Swine Flu (swine influenza) is a disease of pigs. It is a highly contagious respiratory disease caused by one of the many Influenza A viruses. Approximately 1% to 4% of... [more]

April 13, 2009
ION Labs Inc. Recalls Influend Cough and Cold Products, in Alabama, Because Of Possible Health Risk –April 13, 2009
ION Labs Inc. of Clearwater, FL. is voluntarily recalling all of the Influend Cough and Cold products sold on or after May 30, 2008. ION Labs Inc. is Recalling the listed products... [more]

April 08, 2009
FDA Statement on the Voluntary Withdrawal of Raptiva From the U.S. Market
Genentech, the manufacturer of the psoriasis drug Raptiva (efalizumab), announced that it has begun a voluntary, phased withdrawal of the product from the U.S. market. The company... [more]

March 31, 2009
Caraco Pharmaceutical Laboratories, Ltd. Announces a Nationwide Voluntary Recall of All Lots of Digoxin Tablets Due to Size Variability
Caraco Pharmaceutical Laboratories, Ltd. (NYSE AMEX: CPD), a generic pharmaceutical company, announced today that all tablets of Caraco brand Digoxin, USP, 0.125 mg, and Digoxin,... [more]

March 23, 2009
Watson Announces a Nationwide Voluntary Recall of Propafenone HCL Tablets Due to Oversized Tablets
Watson Pharmaceuticals, Inc. (NYSE: WPI), a leading specialty pharmaceutical company, announced today that one lot of Propafenone HCL 225 mg Tablets sold in 100 count bottles in... [more]


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A must read, this article is as close as we get to mainstream media exposing traditional PBMs and the contract and spread pricing problems they create that plague the industry. Click this link to view now.

As you know, Envision is the only PBM that offers total transparency and a guarantee that 100% of all rebates, fees and discounts are passed back to the plan sponsor at the point of sale. And now the word is getting out. As a trusted advisor, we encourage you to share this information with your colleagues and proactively reach out to your clients who may be facing similar challenges. If you have any questions regarding PBMs and transparency, have concerns about clients currently with a traditional PBM, or simply want to learn more about Envision’s Pharmacy Benefit Management Services feel free to contact us.

See below for a link to an article that was just published in Fortune Magazine.This is a quick and easy read that helps to shed light on a sometimes complicated PBM industry. We encourage you to read this and discover how as a transparent PBM, Envision succeeds by being different…Check it out and let us know what you think!

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