Drug Recalls and recalled medical devices from pharmaceutical industry and Food and Drug Administration (FDA) press releases.

Phoenix Import & Distribution Announces Recall Of Pentrexyl Forte Natural Due to Misleading Marketing

May 14, 2011

Phoenix Import & Distribution LLC recalls for PENTREXYL FORTE NATURAL because the packaging is believed to be misleading, causing it to be confused with an antibiotic.

Multi-Mex Distributor Recalls Dietary Supplements Labeled as Antibiotics

May 10, 2011

Multi-Mex Distributor, Inc., Tucker, GA is recalling dietary supplements that may be labeled as antibiotic drugs.

The products were distributed in the following states: Georgia, Tennessee, California, Illinois, Texas, North Carolina, South Carolina, Colorado, and Indianapolis, to the retail store and distributors.

The following products are being recalled:

American Regent Recalls Caffeine & Sodium Benzoate Injection, USP 250 mg/mL, 2 mL Single Dose Vial Due to Visible Particulates

May 6, 2011

Shirley, NY – American Regent is conducting a nationwide voluntary recall to the consumer and user level of the following product: Caffeine & Sodium Benzoate Injection, USP, 250 mg/mL, 2 mL Single Dose Vial,
NDC # 0517-2502-10, Lot #0084,  Exp Date  February, 2012.

Defibtech Recalls DDU-100 series AEDs: Automatic External Defibrillators (AED)

May 3, 2011

Recalled Defibtech AEDDefibtech, LLC has recalled about 65,885 DDU-100 series semi-automatic external defibrillators (AEDs) sold in the United States under the brand names Lifeline AED and ReviveR AED. These recalled defibrillators may, in rare cases, cancel shock while charging, which could cause a failure to resuscitate the patient.

Bristol-Myers Squibb Recalls Coumadin (Warfarin Sodium) Crystalline 5 mg Tablets, Lot Number 9H49374A

May 3, 2011

Bristol-Myers Squibb is recalling 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.

Coumadin is prescribed to treat or prevent blood clots. A decrease of active ingredient may increase the risk of clots which could lead to heart attack or stroke and if there is too much active ingredient, there is an increased risk of bleeding.

Ethos Environmental Recalls Dietary Supplement Regenerect

April 30, 2011

Ethos Environmental, Inc. recalls dietary supplement sold under the brand name Regenerect due to the confirmed the presence of Sulfoaildenafil, an analogue of Sildenafil, making these products unapproved new drugs.  The active drug ingredient, Sulfoaildenafil , is not listed on the label for these products.

American Regent Recalls Ammonium Molybdate Injection, USP (Molybdenum 250mcg/10 mL) 10 mL Single Dose Vial Due to the Presence of Particulate Matter

April 28, 2011

Shirley, NY – American Regent is conducting a nationwide voluntary recall of Ammonium Molybdate Injection, USP (Molybdenum 250mcg/10mL) 10mL Single Dose Vial NDC 0517-6610-25, Lot # 9409, Exp. Date June 2011.

PLEASE NOTE: This recall initiated on April 26, 2011 to the User Level is for Lot # 9409 only. No other lots of Ammonium Molybdate Injection, USP are subject to this recall.

Important Information for Atwater Carey First Aid Kit Consumers Regarding Triad Group’s Povidone Iodine Prep Pads

April 26, 2011

Wisconsin Pharmacal Company, LLC has become aware of a broad United States market recall of Triad Povidone Iodine Prep Pads, manufactured by H&P Industries Inc. and marketed under various brand names including Triad. The Triad Povidone Iodine Prep Pads were included in the Atware Carey First Aid Kits distributed by Wisconsin Pharmacal Company. In the interest of consumer safety, Wisconsin Pharmacal wants to ensure that U.S. consumers using Atwater Carey First Aid Kits are aware of the Triad recall.

The recall of the Triad Povidone Iodine Prep Pad is due to potential contamination of these products with bacteria that could lead to life-threatening infections. Current shipments of Atwater Carey First Aid Kits do not include the Triad Povidone Iodine Prep Pads.

B&M Inc. Recalls Archer Farms Ground Turmeric Due To Excessive Lead Levels.

April 16, 2011

B&M Inc. of Mount Vernon, Missouri announced on April 15, 2011 the recall of Archer Farms Ground Turmeric due to excess lead levels.   The turmeric comes in a glass bottle with a net weight of 2.6 oz. (74g) and is specifically sold at Target stores.
 
The Archer Farms Ground Turmeric was distributed to Target retail stores in the following states from June, 2009, to February, 2010: AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SD, TN, TX, UT, VA, WA, and WI.

Ortho-McNeil Neurologics Recalls Two Lots of TOPAMAX

April 15, 2011

Ortho-McNeil Neurologics Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc., has recalled two lots of TOPAMAX® (topiramate) 100mg Tablets due to complaints of a strange odor, which may be caused by trace amounts of TBA (2,4,6 tribromoanisole), a chemical used as a fungicide.

Moog Recalls Curlin Ambulatory Infusion Pump Models 6000 CMS, 6000 CMS IOD, PainSmart, and PainSmart IOD

April 12, 2011

Moog Inc. announced today that the Food and Drug Administration (FDA) has classified the voluntary correction of the Curlin 6000 CMS, Curlin 6000 CMS IOD, PainSmart, and PainSmart IOD as a Class I recall.

bioMerieux Issues Urgent Expanded Recall for VITEK Piperacillin/Tazobactam Test on Gram Negative Susceptibility Cards Due to Possible Contamination

April 9, 2011

As a follow up to the communication issued on September 16, 2010, bioMérieux, Inc. is expanding its worldwide product recall of VITEK® 2 Gram Negative Susceptibility Cards containing the antibiotic Piperacillin/Tazobactam (TZP). These cards, manufactured after March 10, 2009, are used in clinical laboratories to perform antimicrobial susceptibility testing as part of the VITEK® 2 System. Clinical laboratories have been notified to perform an alternative method of testing prior to reporting results for:

  • Piperacillin/Tazobactam (TZP) and Escherichia coli, Morganella morganii, Proteus mirabilis, Proteus vulgaris, Providencia rettgeri, Providencia stuartii, Pseudomonas aeruginosa and Salmonella enterica

AVNS, Inc. Recalls of THE BEST Enhancer Due to Presence of Sulfoaildenafil

April 5, 2011

AVNS Inc announced today it is recalling THE BEST Enhancer Supplement.  A lab analyses found that the products to contain Sulfoaildenafil, an analogue of Sildenafil, an FDA-approved drug used in the treatment of male Erectile Dysfunction (ED), making these products unapproved new drugs. The active drug ingredient is not listed on the product label.

Centurion Medical Products Recalls Select Central Venous Catheters, PICC Insertions, and VAD Trays Due to Particulate Contamination.

April 2, 2011

Centurion Medical Products Corporation, of Williamston, Michigan, has initiated a recall of certain customized convenience kits that contain Bacteriostatic Sodium Chloride Injection, USP, 0.9% 30 mL Multiple Dose Vials manufactured by Luitpold Pharmaceuticals, Inc., and distributed by American Regent, Inc. This action is in response to American Regent’s recall of three lots of vials because some may contain visible particulates.

CDC And ADPH Investigate Outbreak At Alabama Hospitals; Products Recalled

March 31, 2011

The Alabama Department of Public Health today is announcing an ongoing investigation of an outbreak of Serratia marcescens bacteremia in six Alabama hospitals. On March 16, ADPH was notified that an outbreak had occurred in two of these hospitals among patients receiving TPN (total parenteral nutrition).

Nutrition Express Recalls Protein Supplements Because Of Possible Salmonella Contamination.

March 31, 2011

Nutrition Express of Torrance, CA is recalling specific products containing whey protein isolate sourced from one supplier because they have the potential to be contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems.

Recall of Arnica Flower And Stem Arnica Due To Inaccurate Usage Information On Product Label

March 29, 2011

NAC Foods Corporation is announcing a recall of the Mi Pepito Arnica Flower and Stem Arnica due to inaccurate usage information on the product label. The current label states ‘Use to enhance the flavor of your favorite dish.’ The label should have stated: ‘Recommended for external use only.’

APP Pharmaceuticals Recalls Irinotecan Hydrochloride Injections

March 28, 2011

APP Pharmaceuticals, Inc., (APP) announced today that it has issued a voluntary recall of five lots of Irinotecan Hydrochloride Injection, which is used for recurrent or progressive metastatic colorectal cancer. This recall is being conducted as a precautionary measure and there have been no reports to dates of adverse events related to the recalled products.

Greenstone Recalls Citalopram and Finasteride Due to Possible Mislabeling

March 28, 2011

Greenstone LLC iis recalling medicines with lot number FI0510058-A on the label. Bottles labeled as Citalopram (used to treat depression) may contain Finasteride (used for the treatment of benign prostatic hyperplasia).

Shaping Beauty Recalls Weight Loss Tea Found to Contain Sibutramine

March 25, 2011

Shaping Beauty, Inc. has been informed by the Food and Drug Administration (FDA) that a weight loss dietary supplement sold and marketed by the firm contain an undeclared drug ingredient. FDA lab analyses of dietary supplement tea distributed by the company were found to contain undeclared Sibutramine used as an appetite suppressant for weight loss. The FDA has not approved the following products as drugs; therefore the safety and effectiveness of this product is unknown. All lots of the following dietary supplement products are being recalled:

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