Category Archives: Drug Recalls & Safety Notices

FDA launches initiative to develop innovative external defibrillators

Safety concerns on the devices that treat abnormal heart rhythms also to be addressed. The U.S. Food and Drug Administration today announced a program aimed at facilitating the development of safer, more effective external defibrillators used to treat abnormal heart rhythms through improved design and manufacturing practices.

FDA Urges Consumers to be ‘Smart’ about Antibiotic Use

This year, millions of antibiotics will be prescribed. Antibiotics can be used to treat bacterial infections; however, they are commonly over-prescribed. Patients sometimes ask their health care professional to prescribe antibiotic drugs for viral infections, like the common cold, despite the fact that they will not work and may lead to potentially harmful side effects. The misuse of antibiotics has contributed to one of the world’s most pressing public health problems today, antibiotic resistance.

Mcneil Consumer Healthcare Recalls Four Product Lots of Benadryl® Allergy Ultratab™ Tablets, 100 Count, and One Product Lot of Extra Strength Tylenol® Rapid Release Gels, 50 Count

Fort Washington, PA (June 15, 2010) – McNeil Consumer Healthcare, Division of McNEIL-PPC, Inc., is recalling five product lots as an addition to the list of products included in the company’s January 15th, 2010 product recall. The additional lots involved are four product lots of BENADRYL® ALLERGY ULTRATAB™ TABLETS, 100 count, sold in the U.S.; and one product lot of EXTRA STRENGTH TYLENOL® Rapid Release Gels, 50 count sold in the U.S., Trinidad and Tobago, Bermuda, and Puerto Rico (FULL RECALLED PRODUCT LIST BELOW).

Pfizer Initiates a Nationwide Voluntary Recall of All Lots of Metronidazole Injection, Ciprofloxacin Injection, and Ondansetron Injection Bags Made by Claris Lifesciences Due to Non-Sterility

Pfizer Inc is voluntarily recalling Metronidazole, Ciprofloxacin and Ondansetron IV Products due to the presence of floating matter and non-sterility discovered by the manufacturer Claris Laboratories. Non-sterility of a product administered via the intravenous route has the potential to result in infections, which could be fatal, especially in patients who are immunocompromised. Metronidazole and Ciprofloxacin injections are intravenous antibiotics used to treat infections.

West-Ward Pharmaceuticals Recalls Ondansetron in 5% Dextrose Injection And Metronidazole Injection, USP Bags Due To Possible Health Risk

West-Ward Pharmaceuticals Inc., of Eatontown, NJ, is voluntarily recalling all lots of Claris LifeSciences Inc. manufactured Ondansetron in 5% Dextrose Injection, supplied in 32mg/50mL Single-Use Plastic Bag Containers and Metronidazole Injection 500mg/100ml USP in Flexible IV Plastic Bag Containers. Claris recently received reports of the presence of floating matter and non-sterility in Ondansetron and Metronidazole. Non-sterile products administered intravenously may cause infections which could be fatal especially in patients who are immuno-compromised.

Sagent Pharmaceuticals Initiates a Nationwide Voluntary Recall of All Lots of Ondansetron in 5% Dextrose Injection, 32 mg/50 mL Manufactured by Claris Lifesciences

Sagent Pharmaceuticals, Inc. today announced the voluntary nationwide recall of all lots of ondansetron injection in 5% dextrose 32mg / 50 mL (NDC number 25021-776-50) manufactured by Claris Lifesciences and distributed by Sagent. The lot numbers being recalled are: A090309, A090310, A090311 and A090312, which were distributed to hospitals, wholesalers and distributors nationwide from August 2009 through May 2010. Ondansetron injection is an intravenous product used to treat nausea and vomiting associated with chemotherapy or surgery and is supplied in a single dose plastic container.

Claris Lifesciences initiates a nationwide voluntary recall of all lots of Ciprofloxacin Inj. USP 200 mg / 100 mL, Ciprofloxacin Inj. USP 400 mg / 200 mL, Metronidazole Inj. USP 500 mg/100 ml and Ondansetron Inj., 32 mg / 50 mL.

Claris Lifesciences today announces the voluntary nationwide recall of all lots of Ciprofloxacin Inj. USP 200 mg / 100 mL (NDC 36000-008-24), Ciprofloxacin Inj. USP 400 mg / 200 mL (NDC 36000-009-24), Metronidazole Inj. USP 500 mg/100 ml (NDC 36000-001-24), and Ondansetron in 5% Dextrose Inj. 32 mg / 50 mL (36000-014-06) manufactured and distributed by Claris Lifesciences. All lots are being recalled, which were distributed to hospitals, wholesalers and distributors nationwide.