FDA MedWatch Alerts

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Advocate Redi-Code+ Blood Glucose Test Strips by Diabetic Supply of Suncoast: Recall- Labeling Error

July 22, 2014

Audience: Consumer, Family Physician, Pharmacy. UPDATED 07/22/2014. Class I Recall issued. [Posted 06/11/2014] ISSUE: Diabetic Supply of Suncoast, Inc. initiated a nationwide voluntary recall of all BMB-BA006A Advocate Redi-Code+ blood glucose test strip lots manufactured by BroadMaster Bio-Tech Corp due to a labeling error which could result in confusion about which meter models the Redi-Code+ BMB-BA006A...

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Ibuprofen and Oxcarbazepine Tablets by American Health Packaging: Recall - Mislabeled Packaging

July 21, 2014

Audience: Pharmacy, Neurology, Pain Management, Rheumatology. ISSUE: American Health Packaging (AHP) voluntarily recalled Lot #142588, Expiration Date, 01/2016 of Ibuprofen Tablets, USP, 600 mg, in a hospital unit dose presentation that may contain individual blistered doses labeled as Oxcarbazepine Tablets, 300 mg, lot #142544. In addition, AHP voluntarily recalled Oxcarbazepine Tablets, 300 mg, lot #142544,...

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Sterile Drug Products by Downing Labs (aka NuVision Pharmacy): Drug Alert - Lack of Sterility Assurance

July 19, 2014

Audience: Risk Manager, Health Professionals, Pharmacy, Consumer. ISSUE: FDA is alerting health care professionals and consumers not to use drugs marketed as sterile produced by Downing Labs LLC, also known as NuVision Pharmacy, in Dallas, as they may be contaminated. Administration of a non-sterile drug product intended to be sterile may result in serious and potentially life-threatening infections or death. FDA...

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Baxter IV Sodium Chloride and Potassium Chloride Solutions: Recall - Particulate Matter

July 18, 2014

Audience: Risk Manager, Pharmacy, Nursing. including 0.9% Sodium Chloride 100 mL (Quad Pack) 0.9% Sodium Chloride 100 mL MINI-BAG Plus 0.9% Sodium Chloride, 50 mL (Single Pack) Highly Concentrated Potassium Chloride Injection, 20 mEq/50 mL, VIAFLEX Plus Container [Posted 07/18/2014] ISSUE: Baxter International Inc. initiated a voluntary recall of four lots of intravenous (IV) solutions to the hospital/user...

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Sterile Drug Products by Unique Pharmaceuticals Ltd.: Alerting Health Care Professionals - Lack of Sterility Assurance

July 11, 2014

Audience: Risk Manager, Health Professionals, Pharmacy. ISSUE: The U.S. Food and Drug Administration is alerting health care professionals, including hospital supply managers and hospital staff, not to use drugs marketed as sterile produced by Unique Pharmaceuticals Ltd., a company located in Temple, Texas, as they may be contaminated.  Administration of a non-sterile drug product intended to be sterile may result...

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Hospira Lactated Ringer's And 5% Dextrose Injection, 1000 ML, Flexible Containers: Recall (One Lot) - Mold Contamination

July 11, 2014

[Posted 07/11/2014] AUDIENCE: Pharmacy, Risk Manager ISSUE: Hospira, Inc. announced it is initiating a voluntary nationwide user-level recall of one lot of Lactated Ringers and 5% Dextrose Injection, USP, 1000 mL, Flexible Container, NDC 0409-7929-09, Lot 35-118-JT, Expiry 1NOV2015 . This action is due to one confirmed customer report where particulate was identified within the solution of the primary container....

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Sterile Drug Products by Unique Pharmaceuticals Ltd.: Recall - Lack of Sterility Assurance

July 11, 2014

[Posted 07/11/2014] AUDIENCE: Risk Manager, Health Professionals, Pharmacy ISSUE: The U.S. Food and Drug Administration is alerting health care professionals, including hospital supply managers and hospital staff, not to use drugs marketed as sterile produced by Unique Pharmaceuticals Ltd., a company located in Temple, Texas, as they may be contaminated. Health care professionals should immediately check their...

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Weight Loss Products: Public Notification - Undeclared Drug Ingredients

July 9, 2014

Audience: Consumer. Including: Mix Fruit Slimming Lingzhi Cleansed Slim Tea 24 Ince Lipo 8 Burn Slim Capsules Sliming (sic) Diet By Pretty White Trim-Fast Slimming Softgel [Posted 07/09/2014] ISSUE: The FDA is advising consumers not to purchase or use Mix Fruit Slimming, Lingzhi Cleansed Slim Tea, 24 Ince, Lipo 8 Burn Slim Capsules, Sliming (sic) Diet By Pretty White, and Trim-Fast Slimming Softgel...

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Coumadin (warfarin sodium) for Injection by Bristol-Myers Squibb: Recall - Particulate Matter

July 1, 2014

Audience: Cardiology, Health Professionals. ISSUE:  Bristol-Myers Squibb Company issued a voluntary recall of six lots of Coumadin for Injection, 5 mg single-use vials in the U.S. Visible particulate matter was found in a small number of Coumadin for Injection unreleased samples. Injected particulate metallic and non-metallic cellulose material can cause serious and potentially fatal adverse reactions such as...

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Medical Supply Liquidators Injectable Vitamin Products With a "Sunshine Labs" Label: Warning - Products Not FDA Approved

June 30, 2014

Audience: Health Professionals. ISSUE: FDA alerted health care professionals not to use injectable vitamin drug products distributed by Medical Supply Liquidators LLC in Clive, Iowa, with “Sunshine Labs” on the label. These products are manufactured by Compound Brothers Dominicana (also known as CB Inc.) in the Dominican Republic and sold as prescription injectable nutritional supplements. FDA has not approved...

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Lidocaine Viscous: Drug Safety Communication - Boxed Warning Required - Should Not Be Used to Treat Teething Pain

June 26, 2014

Audience: Consumer, Pediatrics, Family Practice. ISSUE: FDA notified health professionals, their provider organizations and caregivers for infants, that prescription oral viscous lidocaine 2% solution should not be used to treat infants and children with teething pain. FDA is requiring a Boxed Warning to be added to the prescribing information (label) to highlight this information. Oral viscous lidocaine solution is...

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Over-The-Counter Topical Acne Products: Drug Safety Communication - Rare But Serious Hypersensitivity Reactions

June 25, 2014

Audience: Consumer, Pharmacy, Family Practice. Sold under various brand names such as Proactiv, Neutrogena, MaxClarity, Oxy, Ambi, Aveeno, Clean & Clear, and as store brands. [Posted 06/25/2014] ISSUE: FDA is warning that certain over-the-counter (OTC) topical acne products can cause rare but serious and potentially life-threatening allergic reactions or severe irritation. Consumers should stop using their...

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Red Yeast Rice by Doctor’s Best: Recall - Undeclared Lovastatin

June 24, 2014

Audience: Consumer. ISSUE: Doctor’s Best is voluntarily recalling lot 3121005 (7379 bottles) of Red Yeast Rice dietary supplement, 600 mg Capsules, 120-count bottles to the retail level. Doctor’s Best Red Yeast Rice has been found to contain undeclared lovastatin, a previously approved drug indicated for the treatment of high cholesterol, making this an unapproved new drug. Consumers who use supplements found...

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Olmesartan: Drug Safety Communication - FDA Review Finds Cardiovascular Risks for Diabetics Not Conclusive

June 24, 2014

Audience: Cardiology, Pharmacy, Family Practice, Endocrinology. Includes: Benicar, Benicar HCT, Azor, Tribenzor, and Generics [Posted 06/24/2014] ISSUE: FDA has completed its safety review and has found no clear evidence of increased cardiovascular risks associated with use of the blood pressure medication olmesartan in diabetic patients (see previous alerts linked below). FDA believes the benefits of...

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Testosterone Products: FDA/CDER Statement - Risk of Venous Blood Clots

June 20, 2014

Audience: Pharmacy, Primary Care. [Posted 06/20/2014] ISSUE:  FDA notified health professionals and their medical care organizations that it is requiring the manufacturers of all approved testosterone products to include a warning in the drug labeling about the risk of blood clots in the veins, also known as venous thromboembolism (VTE), including deep vein thrombosis (DVT) and pulmonary embolism...

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Docetaxel: Drug Safety Communication - May Cause Symptoms of Alcohol Intoxication

June 20, 2014

Audience: Oncology. ISSUE: FDA is warning that the intravenous chemotherapy drug docetaxel contains ethanol, also known as alcohol, which may cause patients to experience intoxication or feel drunk during and after treatment. FDA is revising the labels of all docetaxel drug products to warn about this risk.  BACKGROUND: Docetaxel is a prescription chemotherapy drug used to treat different kinds of cancer,...

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Male Sexual Enhancement Products: Immediate Public Notification: Undeclared Drug Ingredients

June 19, 2014

Audience: Consumer. Including: GoldReallas Full Throttle On Demand 3 Hard Knights Dick’s Hard Up Eyeful Liu Bian Li  Zhen Gong Fu Gold Vigra (contains sildenafil) Miraculous Evil Root (contains sildenafil)   UPDATED 06/19/2014. Gold Vigra, Miraculous Evil Root Public Notification added. UPDATED 06/06/2014. Zhen Gong Fu Public Notification added. [Posted 06/03/2014] ISSUE: The FDA is advising...

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Weight Loss Products: Immediate Public Notification: Undeclared Drug Ingredients

June 19, 2014

Audience: Consumer. Including: Sport Burner (contains fluoxetine) Toxin Discharged Tea (contains fluoxetine) Sliming Diet (contains sibutramine)   [Posted 06/19/2014] ISSUE: FDA is advising consumers not to purchase or use these products, promoted and sold for weight loss on various websites and in some retail stores. FDA laboratory analysis confirmed that these products contain sibutramine or...

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Marcaine (Bupivacaine HCI Injection, USP), 0.5 percent, 30 ML, Single-Dose, Preservative-Free Vial: Recall - Visible Particulates

June 18, 2014

Audience: Risk Manager, Pharmacy. [Posted 06/18/2014] ISSUE: Hospira announced a voluntary nationwide recall to the user level for one lot of 0.5% Marcaine (Bupivacaine HCl Injection, USP), 30 mL, Single-dose Vial – Preservative Free (NDC 0409-1560-29), Lot 33-545-DD. The recall is due to a confirmed customer report of particulate embedded in the glass vial as well as visible particulate in the solution....

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Captomer and Captomer-250 by Thorne Research: FDA Warning - Potential Health Risks

June 13, 2014

Audience: Consumer. [Posted 06/13/2014] ISSUE: FDA is warning consumers not to purchase or to use Thorne Research’s Captomer or Captomer-250, marketed as a dietary supplement for heavy metal toxicity and heavy metal chelation therapy. The products list DMSA (meso-2, 3-dimercaptosuccinic acid), as an active ingredient, which is contained in an FDA-approved prescription product indicated for the treatment of...

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