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Lidocaine HCI Injection, USP 10 MG Per ML, 30 ML Single-Dose, Preservative-Free, by Hospira: Recall - Particulate Matter

October 17, 2014

Audience: Pharmacy, Patient, Nursing. ISSUE: Hospira announced it will initiate a voluntary recall of one lot of 1% Lidocaine HCI for Injection, USP, 10 mg per mL, 30 mL Single-dose, Preservative-Free to the user level due to a confirmed customer report of particulate in a single unit. Hospira has identified the particulate as a human hair, embedded in and attached to a pinched area of the stopper. To date, Hospira...

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LifeCare Flexible Intravenous Solutions by Hospira, Inc.: Recall - Potential for Leakage

October 15, 2014

Audience: Pharmacy, Nursing, Risk Manager. ISSUE: Hospira, Inc. announced the voluntary recall of certain lots of several products in its LifeCare line of flexible intravenous solutions due to the potential for leakage. The issue was identified during re-inspection of a manufactured product lot in which a single puncture mark was identified going through the overwrap and primary container. The puncture in the...

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Oregon Compounding Centers, Inc. Unexpired Sterile Products: Recall - Lack of Sterility Assurance

October 10, 2014

Audience: Health Professional, Pharmacy, Veterinary. [Posted 10/10/2014] ISSUE: Oregon Compounding Centers, Inc., also called Creative Compounds, is voluntarily recalling certain unexpired human and veterinary sterile products to the consumer level due to lack of sterility assurance. The company has not received any reports of product contamination or adverse events to date, but is issuing this voluntary recall...

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Sit and Slim II: Public Notification - Hidden Drug Ingredients

October 10, 2014

Audience: Consumer. [Posted 10/10/2014] ISSUE: The Food and Drug Administration (FDA) is advising consumers not to purchase or use Sit and Slim II. FDA laboratory analysis confirmed that Sit and Slim II contains sibutramine. Sibutramine is a controlled substance that was removed from the market in October 2010 for safety reasons. The product poses a threat to consumers because sibutramine is known to...

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SAM Junctional Tourniquet Accessory (Axilla) Strap - SAM Medical Products: Recall - Potential Clip Failure

October 8, 2014

Audience: Emergency Medicine, Critical Care Medicine, Risk Manager. [Posted 10/08/2014] ISSUE: SAM Medical Products notified customers of a voluntary recall to address a potential issue with a clip used to secure the accessory strap used for the Axilla application of the SAM Junctional Tourniquet (SJT). The company has not received any reports of patient injuries to date related to this issue nor has it been...

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Vancomycin Hydrochloride for Injection USP, Equivalent to 1 Gram Vancomycin (Sterile Powder) by Hospira, Inc.: Recall - Uncontrolled Storage During Transit

October 8, 2014

Audience: Pharmacy, Nursing, Health Professional. ISSUE: Hospira, Inc. issued a voluntary nationwide user-level recall of one lot of Vancomycin Hydrochloride for Injection, USP, Equivalent to 1 g Vancomycin (Sterile Powder), NDC 0409-6533-01, Lot 35-315-DD with expiration date of 01 NOV 2015. The product may have experienced temperature excursions during shipment to a customer and then was further distributed by the...

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Ketorolac Tromethamine Injection, USP, 30mg/ml by Sagent Pharmaceuticals: Recall - Incorrect Labeling

October 6, 2014

Audience: Pharmacy, Risk Manager, Nursing. ISSUE: Sagent Pharmaceuticals, Inc. issued a voluntary nationwide recall of three lots (lot numbers: MP5021, MP5024 and MP5025) of Ketorolac Tromethamine Injection, USP, 30mg/mL single-dose vials (NDC numbers 25021-701-01 and 25021-701-02) manufactured by Cadila Healthcare Limited and distributed by Sagent. The affected product was labeled with the incorrect expiration...

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Bo Ying Compound by Eu Yan Sang (Hong Kong) Ltd: FDA/CDER Statement - Risk of Lead Poisoning

September 26, 2014

Audience: Consumer, Health Professional, Pediatrics, Family Practice. [Posted 09/26/2014] ISSUE: FDA warns parents and caregivers not to use “Bo Ying compound” manufactured by Eu Yan Sang (Hong Kong) Ltd. due to the potential lead poisoning risk associated with the product. FDA learned of this risk from the New York City Department of Health & Mental Hygiene after the product was tested and found to contain...

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Xolair (omalizumab): Drug Safety Communication - Slightly Elevated Risk of Cardiovascular and Cerebrovascular Serious Adverse Events

September 26, 2014

Audience: Allergy and Immunology, Pharmacy, Health Professional. ISSUE: An FDA review of safety studies suggests a slightly increased risk of problems involving the heart and blood vessels supplying the brain among patients being treated with the asthma drug Xolair (omalizumab) than in those who were not treated with Xolair. As a result, FDA has added information about these potential risks to the drug label. The...

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Potassium Chloride Injection (Baxter): Recall - Shipping Carton Mislabeling

September 17, 2014

Audience: Pharmacy, Risk Manager, Nursing. ISSUE: Baxter International Inc. announced a voluntary recall of one lot of Potassium Chloride Injection 10mEq per 100mL, product code 2B0826 (Lot # P318220, NDC # 0338-0709-48) to the hospital/pharmacy/nurse level. The recall is being initiated due to a labeling error on the shipping cartons in a single lot. Shipping cartons labeled for this specific lot number of...

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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...

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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...

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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...

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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....

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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...

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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...

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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...

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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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