01 February 2010

Teva Animal Health, Inc. expands nationwide ketamine recall

Date: January 14, 2010

On December 22, 2009, the U.S. Food and Drug Administration (FDA) announced a nationwide voluntary recall of ketamine hydrochloride injectable (100mg/ml, 10 ml vials) manufactured by Teva Animal Health, Inc. Not all Teva products are affected by the recall. Teva Animal Health also manufactures ketamine hydrochloride products for other companies. These products are sold under various brand names and can include the following:

AmTech Group, Inc. (Ketamine Hydrochloride Injection, USP)
Butler (KetaThesia)
LLOYD Laboratories (VetaKet)
Phoenix (Ketaject)
RXV (Keta-Sthetic)
VEDCO (KetaVed)
Fort Dodge/Pfizer (Ketaset)
Teva Animal Health does not distribute products internationally.

Teva Animal Health is not the only manufacturer of ketamine hydrochloride in the U.S. and not all products sold under the above-listed names listed are affected. Therefore, regardless of the brand name on the product, look at the lot number on all ketamine hydrochloride (100 mg/ml in 10 ml vials) products.

If the lot number is 6 numeric digits, the product is NOT part of the recall
If the lot number is 7 numeric digits, the product should be returned
If the lot number starts with "5401", regardless of the number of digits or the presence of letters in the lot code, the product should be returned
Veterinarians with questions may contact Teva Animal Health at 800-759-3664 from 8:00 am – 5:00 pm (CST) Monday through Friday.


FOR IMMEDIATE RELEASE -- 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.