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FDA Issues Recall for Ketamine

Drug used as part of anesthesia protocol may be linked to deaths.

News item written by Mary Straus, published in the Whole Dog Journal, March 2010.

On December 21st, the FDA’s Center for Veterinary Medicine announced the expansion of a nationwide recall of ketamine hydrochloride injectable manufactured by Teva Animal Health following reports linking the drug to the deaths of five cats. Ketamine is commonly used as part of anesthesia induction in both dogs and cats. The first deaths linked to ketamine occurred in October and were reported to Teva in November and to the FDA in December, 2009.

Since the initial recall began, more products have been added. As of this writing, all lot numbers that are 7 numeric digits long or that start with “5401” (regardless of their length) have been recalled and should be returned to their distributors. After veterinarians pressured the FDA, it was revealed that Teva also manufactures ketamine for other companies, and the recall was expanded to include the following products:

New information came to light in January that the these drugs had actually been quietly recalled last September, with Teva telling distributors to “cease distribution,” but leaving it up to them whether to notify veterinarians or request return of products already sold, which most did not do. In addition to ketamine, this recall included butorphanol tartrate injection, a drug used for pain control. Brands recalled include Equanol (Vedco), Torphaject (Butler), and ButorJect (Phoenix). While this drug has not been linked to deaths, it was not manufactured properly and could therefore be either dangerous or ineffective.

Further investigation revealed that propofol injectable was also recalled in July 2009, after it caused adverse effects in human patients due to contamination with endotoxin bacteria. This drug is manufactured by Teva Pharmaceutical rather than Teva Animal Health. Recalled lot numbers include 100-ml vials in lots 31305429B, 31305430B and 31305324B, 20-ml vials in lot 31305323B, and 50-ml vials in lot 31305431B. Propofol is also used by veterinarians to induce anesthesia. [Update May 2010: Teva announced it will no longer manufacture propofol.]

Ketamine, butorphanol, and propofol are not drugs that pet owners would give themselves, but if your pet is scheduled to be anesthetized, you should check with your vet to be sure that they have all the relevant information about the recall. Veterinarians with questions can contact Teva Animal Health at 800-759-3664.

Troubles at Teva Animal Health began in July 2009, when the FDA shut down the company and filed a lawsuit after inspectors found adulterated animal drugs at its plant in St. Joseph, Missouri. As a result of the FDA probe of its quality control procedures, Teva agreed to cease manufacture of its generic drugs as well as its DVM Pharmaceuticals product line. At that time, however, none of the drugs Teva produced were considered harmful, an assumption that now appears to be incorrect. Production problems go back much further, and the recalled drugs may have been distributed as far back as 2006.

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