Recalls

Moog Medical Devices Group Recalls Curlin Administration Sets

Use of the affected sets could cause desanguination, under-delivery of prescribed medication or therapy delay.

Moog Medical Devices Group (MMDG) is issuing a voluntary recall for certain lots of Curlin Intravenous Administration Sets. Use of the affected sets may cause desanguination (blood loss), an under-delivery of prescribed medication/fluid, or a potential delay in therapy. Continued use of the affected administration sets may cause a potential risk of serious injury or death.

The following REF (catalog) and lot numbers, which were sold and distributed in the U.S. between December 2011 and May 2012, are included in the recall:

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Hospira Recalls Morphine Sulfate Injection Syringes

The company issued the recall after customers reported detecting syringes containing more than the labeled fill volume.

Hospira Inc. is initiating a voluntary user level recall of one lot of Morphine Sulfate Injection USP, 4 mg/mL (C-II), 1 mL fill in 2.5 mL Carpuject, NDC 0409-1258-30, due to a customer report of two Carpujects syringes containing more than the 1 mL labeled fill volume.

Opioid pain medications such as morphine have life-threatening consequences if overdosed.  Those consequences can include respiratory depression (slowed breathing or suspension of breathing), and low blood pressure.

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American Regent Recalls Cyanocobalamin Vials

The injectable treatment, prescribed for patients with B12 deficiencies, is being recalled due to cracks discovered in certain vials.

American Regent is conducting a nationwide voluntary recall to the Retail/Hospital level of the following product:

Cyanocobalamin Injection, USP, 100 mcg/mL, 1 mL Vial NDC # 0517-0031-25Lot # 1662, Exp Date: November, 2013Lot # 1679, Exp Date: November, 2013
Lot # 1683, Exp Date: November, 2013

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Labeling Error Spurs Recall of Baxter Biologic

Baxter Healthcare Corp. has recalled vials of GAMMAGARD LIQUID 10%, 20g, due to incorrect manufacturing and expiration dates.

PRODUCT / LOT NUMBER:
GAMMAGARD LIQUID, [Immune Globulin Intravenous (Human)] 10%, 20g size
Product Code 1502797
NDC # 0944-2700-06
 
MANUFACTURER:
Baxter Healthcare Corp.
Westlake Village, CA
 
REASON:

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OTC ‘Female Intimacy’ Drug Recalled

Packages of RegenArouse, a drug designed to enhance female sexual health, are being recalled because they may contain a male ED drug.

Regeneca, Inc. announced today that it is conducting a voluntary nationwide recall of RegenArouse, Lot Number 130100, because FDA lab analysis has confirmed the presence of Tadalafil making these products unapproved new drugs. Tadalafil is an FDA-approved drug used as treatment for male Erectile Dysfunction (ED). The active drug ingredient is not listed on the label for these products.

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Pfizer Issues Recall for Lo/Ovral-28 and Norgestrel/Ethinyl Estradiol Tablets

The company has voluntarily recalled 14 lots of the drugs after determining some blister packs may contain an inexact count of inert or active ingredient tablets and that the tablets may be out of sequence.

NEW YORK, N.Y. – Pfizer Inc. announced today 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 (generic) for customers in the U.S. market. An investigation by Pfizer found that some blister packs may contain an inexact count of inert or active ingredient tablets and that the tablets may be out of sequence.

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Rexall Recalls Calcium Plus Vitamin D Softgel Packages

The supplements manufacturer has issued a recall of its calcium-vitamin D supplements, because a packaging mixup led to tablets containing a potential allergen. The bottles actually contain glucosamine, which contains ingredients derived from shellfish and could cause adverse reactions.

Rexall, Inc., of Deerfield Beach, Fla., announced a recall of Rexall Calcium 1200 mg plus 1000IU Vitamin D3, 60 softgels. The affected bottles actually contain a TABLET product, Triple Strength Glucosamine Chondroitin and MSM Tablets.

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Broken Tablets, Possible Mix-Ups in Packaging Lead Novartis to Recall Certain OTC Drugs

Packaging inconsistencies as well as broken or chipped tablets have prompted Novartis Consumer Health Inc. (NCH) to conduct a sweeping recall.

Visible Particulates in Vials Prompt American Regent Recall

American Regent reports on FDA's Web site that the company is recalling Caffeine & Sodium Benzoate Injection, USP, 250 mg/mL, 2 mL Single Dose Vial, NDC # 0517-2502-10. The recall only affects lot #0084. No other lots of Caffeine & Sodium Benzoate Injection, USP are subject to this voluntary recall, the company reports.

Bristol-Myers Squibb Initiates a Nationwide Voluntary Recall of Coumadin Crystalline 5 mg Tablets

Bristol-Myers Squibb initiated a voluntary recall of one lot of 1,000-count bottles of Coumadin (warfarin sodium) Crystalline 5 mg tablets. Bottles of 1,000 tablets are distributed to pharmacies for further dispensing to patients in prescription quantities. The lot number affected in the U.S. is 9H49374A with an expiry date of September 30, 2012. The recall is a precautionary measure based on the company's testing of tablets from a returned bottle. A single tablet was found to be higher in potency than expected.
 

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