FDA MedWatch Alerts

FDA Label Changes are now available online and in our monthly newsletter update.

Get alerts by email or subscribe to our news feeds.

Heparin Sodium, 1,000 USP Heparin Units/500 mL (2 USP Heparin Units/mL), In 0.9 percent Sodium Chloride Injection, 500 mL by Hospira: Recall - Particulate Matter

September 12, 2014

Audience: Pharmacy, Risk Manager. ISSUE: Hospira, Inc. announced a voluntary nationwide user-level recall of one lot of Heparin Sodium, 1,000 USP Heparin Units/500 mL (2 USP Heparin Units/mL), in 0.9% Sodium Chloride Injection, 500 mL, NDC 0409-7620-03 Lot 41-046-JT with expiration date of 01NOV 2015. This action is due to one confirmed customer report of particulate in a single unit. The foreign particle was...

Read more...

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

September 9, 2014

Audience: Risk Manager, Health Professionals, Pharmacy, Consumer. [UPDATED 09/09/2014] The FDA has issued a formal request to Downing Labs for the immediate recall of all lots of its purportedly sterile products currently on the market that are not expired. In the letter, the FDA outlined poor conditions and practices identified by FDA investigators during a July 2014 inspection of Downing Labs’ Dallas...

Read more...

Pharmacy Creations Certain Products: Recall – Potential Non-Sterility

September 6, 2014

Audience: Pharmacy, Patient . [Posted 09/06/2014] ISSUE: Pharmacy Creations has voluntarily recalled four product lots (see firm Press Release) following testing results conducted that indicated that the product lots may have the potential of not being sterile. Although we cannot be certain that the product subject to the recall is contaminated, to the extent it was, there are serious health implications for the...

Read more...

Sterile Convenience Surgical Packs by Customed, Inc.: Recall - Potential Loss of Sterility

September 5, 2014

Audience: Risk Manager, Surgery, Nursing. UPDATED 09/05/2014. Recall Classified as Class I. [Posted 08/26/2014] ISSUE: Customed, Inc. initiated a recall of sterile convenience surgical packs. The products have been found to have a potential defect due to adhesion. The defect could result in loss of product sterility and lead to infection. No serious injuries or deaths have been reported as of August 21, 2014....

Read more...

RegeneSlim Appetite Control Capsules: Recall - Presence Of DMAA

September 2, 2014

Audience: Consumer. UPDATED 09/02/2014. Voluntary nationwide recall expanded to include lot #823230415, lot #EX0616r 15813, Lot # EX0616R15814, and Lot #11414re5516. [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...

Read more...

Dermatend Original and Dermatend Ultra: Recall - Safety Concerns

September 2, 2014

Audience: Consumer. [Posted 09/02/2014] ISSUE: Solace International, Inc. is voluntarily recalling all lots of Dermatend Original and Dermatend Ultra, in all sizes and dosage forms, to the distributor/wholesaler level. A mole should be removed under the supervision of a dermatologist. Dermatend is not FDA approved, thus has not been shown to be safe and effective for the uses suggested in the labeling. Using these...

Read more...

Martin Avenue Pharmacy, Inc. Compounded Sterile Preparations: Recall - Lack of Assurance of Sterility

September 2, 2014

Audience: Pharmacy, Patient. ISSUE: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all in-date compounded sterile preparations. The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to sterility assurance. If the sterility of a compounded preparation is compromised, a patient is at risk for...

Read more...

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...

Read more...

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...

Read more...

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...

Read more...

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...

Read more...

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...

Read more...

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....

Read more...

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...

Read more...

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,...

Read more...

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...

Read more...

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...

Read more...

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...

Read more...

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,...

Read more...

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...

Read more...
Older articles
Hide
(web1)