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Dianeal Low Calcium (2.5mEq/L) Peritoneal Dialysis Solution with 2.5 Percent Dextrose 5000mL (Ambu-Flex II): Recall - Presence of Particulate Matter

August 15, 2014

Audience: Pharmacy, Nursing, Nephrology. [Posted 08/15/2014] ISSUE: Baxter International Inc. announced a voluntary recall in the United States of two lots of Dianeal Low Calcium (2.5mEq/L) Peritoneal Dialysis Solution with 2.5% Dextrose 5000mL (Ambu-Flex II) to the hospital/user level. The recall was initiated due to the presence of oxidized stainless steel, garment fiber, and PVC particulate matter identified...

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IPM Wound Gel by Edwards Pharmaceuticals: Class I Recall - Microbial Contamination

August 12, 2014

Audience: Dermatology, Risk Managers, Surgery, Endocrinology, Nursing. ISSUE:  IPM Wound Gel Lot # 3P3446 by Wellspring Pharmaceutical Corporation and distributed by Edwards Pharmaceuticals Inc. is being recalled. The lot of IPM Wound Gel may be contaminated with bacteria (Pseudomonas Putida). IPM Wound Gel is used primarily in hospitals for wound care; the over-the-counter IPM Wound Gel is not included in this...

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Herbal Vigor Quick Fix: Public Notification - Undeclared Drug Ingredient

August 11, 2014

Audience: Consumer. [Posted 08/11/2014] ISSUE: FDA is advising consumers not to purchase or use Herbal Vigor Quick Fix, a product promoted and sold for sexual enhancement. FDA laboratory analysis confirmed that Herbal Vigor Quick Fix contains tadalafil, the active ingredient in the FDA approved prescription drug Cialis, used to treat erectile dysfunction (ED). This undeclared ingredient may interact with...

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Arize: Public Notification - Undeclared Drug Ingredient

August 11, 2014

Audience: Consumer. [Posted 08/11/2014] ISSUE: FDA is advising consumers not to purchase or use Arize, a product promoted and sold for sexual enhancement. FDA laboratory analysis confirmed that Arize contains sulfoaildenafil. Sulfoaildenafil is structurally similar to sildenafil, the active ingredient in Viagra, an FDA approved prescription drug for erectile dysfunction (ED). This undeclared ingredient may...

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CUBICIN (daptomycin for injection) 500 mg in 10 mL Single Use Vials: Recall - Foreign Particulate Matter

August 9, 2014

Audience: Risk Manager, Health Professional, Pharmacy, Nursing. ISSUE: Cubist Pharmaceuticals, Inc.is voluntarily recalling nine lots of CUBICIN (daptomycin for injection) to the user level following complaints of foreign particulate matter in reconstituted vials.  Refer to the Press Release for a list of affected products.  The administration of particulate matter, if present in an intravenous drug, poses a...

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White and Blue Lion Tattoo Kits: Recall - Bacterial Contamination of Needles and Ink Bottles

August 8, 2014

Audience: Dermatology, Primary Care Provider, Nursing. [Posted 08/08/2014] ISSUE: FDA is notifying health professionals and their patients of the voluntary recall of White and Blue-branded tattoo inks and needles due to confirmed bacterial contamination in unopened bottles of inks and on needles included in tattoo kits. FDA is concerned that consumers are continuing to use contaminated inks for tattoos....

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Cubicin (daptomycin for injection) 500 mg in 10 mL Single Use Vials: Recall - Presence Of Particulate Matter

August 7, 2014

Audience: Pharmacy, Nursing. ISSUE: Cubist Pharmaceuticals, Inc. announced a recall of certain lots of Cubicin (daptomycin for injection) to the user level due to the potential presence of glass particulate matter in vials produced by a contract manufacturer. See the Press Release for a listing of affected lot numbers. The administration of a glass particulate, if present in an intravenous drug, poses a potential...

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RegeneSlim Appetite Control Capsules: Recall - Presence Of DMAA

August 7, 2014

Audience: Consumer. [Posted 08/07/2014] ISSUE: Regeneca Worldwide a division of VivaCeuticals, Inc., is conducting a voluntary nationwide recall of its appetite control dietary supplement, lot # EX0616R15814 and lot #11414RE5516, because FDA analysis confirmed the presence of DMAA. DMAA, also known as 1,3-dimethylamylamine, methylhexanamine, or geranium extract, is commonly used as a stimulant, pre-workout,...

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Expression Injectable by Enhancement Medical: FDA Safety Communication - Adverse Events Associated with Unapproved Use As a Dermal Filler

August 5, 2014

Audience: Dermatology, Surgery, Dentistry, Nursing. ISSUE: The FDA has become aware of adverse events associated with the unapproved use of the Expression product, hyaluronic acid that is packaged in a syringe, as a dermal filler. Events have included swelling, tenderness, firmness, lumps, bumps, bruising, pain, redness, discoloration, itching, and the development of hard nodules. BACKGROUND: Expression is listed...

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Lidocaine HCl Injection, USP, 2 percent, by Hospira: Recall - Visible Particulates

July 30, 2014

Audience: Pharmacy, Patient, Health Professional, Nursing. ISSUE: Hospira, Inc. is recalling one lot of Lidocaine HCl Injection, USP, 2%, 20 mg per mL, 5 mL single-Dose Vial, Preservative-Free (NDC 0409-2066-05; Lot 25-550-DD, Expiry 1JAN2015) to the user level due to a confirmed customer report of discolored product with visible particles in the solution as well as particulate embedded in the molded glass...

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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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