Wednesday, January 6, 2010

Teva Expands Nationwide Recall of Ketamine

Teva Animal Health Inc. is expanding a nationwide recall of its Ketamine Hydrochloride Injection which effect products under seven manufacturer’s labels because of adverse events including the death of some animal patients. The labels include specific lots of Ketamine products from Fort Dodge Animal Health, Vedco, AmTech Group, Butler, Phoenix Pharmaceuticals, Rx Veterinary Products and Lloyd Laboratories. This enhanced recall energizes the need for material screening of products within the supply chain to protect consumers from fraud, adulteration, contamination and counterfeit products. The following press releases include details on the recall:

Teva Animal Health, Inc. Expands a Voluntary Nationwide Recall of Ketamine Hydrochloride Injection, USP CIII 100mg/mL in 10mL vials

December 21, 2009 - Teva Animal Health, Inc. is expanding a nationwide voluntary recall of Ketamine Hydrochloride Injection, USP CIII 100mg/mL in 10mL vials for all lot numbers within their expiration dates to the Veterinary Level. This product had previously been recalled to the distributor level and is being expanded as a result of an increased trend in serious adverse events associated with this product.

Veterinarians who have this product in their possession are instructed to cease using the product immediately and return it to their distributor.

Ketamine Hydrochloride is a rapid acting, non-narcotic, non-barbiturate agent for anesthetic use in cats and for restraint in subhuman primates. This recall is being conducted as a result of an increased trend in serious adverse events associated with this product, including lack of effect, prolonged effect, and death and involves all lot numbers within expiration.

Teva Animal Health, Inc is voluntarily recalling the aforementioned product. The FDA has been apprised of this action.

Consumers with questions may contact 800-759-3664 from 8:00am – 5:00pm CST Monday-Friday.

Seven Labels Tied to Teva Ketamine Recall, FDA says

In the wake of Teva Animal Health’s massive ketamine recall, the U.S. Food and Drug Administration (FDA) reports that the action extends to lot numbers of Fort Dodge Animal Health’s Ketaset, Vedco’s Ketaved and five other private labels.

An e-mail to the VIN News Services (VNS) from the FDA’s Center for Veterinary Medicine (CVM) confirms that the labels include:

  • AmTech Group Inc. Ketamine Hydrochloride Injection, USP, manufactured by IVX Animal Health Inc..
  • Butler KetaThesia, distributed exclusively by Butler Animal Health Supply, Dublin, Ohio
  • Fort Dodge Ketaset, manufactured for Fort Dodge Animal Health, Fort Dodge, Iowa
  • VEDCO KetaVed, distributed by Vedco Inc., St. Joseph, Mo.
  • Phoenix Ketaject, manufactured for Phoenix Pharmaceutical Inc., St. Joseph, Mo.
  • LLOYD Laboratories VetaKet, manufactured for Lloyd Laboratories in
  • Shenandoah, Iowa
  • RXV Keta-Sthetic, manufactured for RXVeterinary Products, Westlake, Texas
This latest recall stems from the reported death of five cats, inconclusively linked to the drug's use. But troubles within Teva Animal Health surfaced last July, when the FDA shut down the company via a permanent injunction and filed a lawsuit, alleging that regulatory inspectors had uncovered adulterated animal drugs at Teva’s main facilities in St. Joseph, Mo. The generics manufacturer agreed to cease production of its drugs and its DVM Pharmaceuticals line of products following FDA's much-publicized crackdown on the company’s quality control practices.

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