Clarification of Teva Animal Health Recalls: Ketamine Hydrochloride & Butorphanol Injections

Customer Service: (800) 759-3664

Web: www.tevaanimalhealth.com

Ketamine Hydrochloride Injections Recalled at Customer Level

Teva Animal Health, Inc. is expanding a nationwide 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 to the customer level as a result of an increased trend in serious adverse events associated with this product. 

  • Not all Teva products are affected by the recall.

  • Teva Animal Health also manufactures ketamine products for other companies.

  • These products are sold under various brand names, including:

    • AmTech Group, Inc. (Ketamine Hydrochloride Injection, USP)

      • 6111887, Exp. Nov-09
        6121994, Exp. Dec-09
        6122045, Exp. Dec-09
        7010148, Exp. Jan-10
        7081091, Exp. Aug-10

    • Butler (KetaThesia)

      • 6101617, Exp. Oct-09
        6121994, Exp. Dec-09
        7010043, Exp. Jan-10
        7010101, Exp. Jan-10
        7010148, Exp. Jan-10
        7030369, Exp. Mar-10
        7060835, Exp. Jun-10
        7070963, Exp. Jul-10
        7081091, Exp. Aug-10

    • Fort Dodge (Ketaset)

      • 540186K, Exp. Sep-11
        540186L, Exp. Sep-11
        54018W7, Exp. Oct-11
        54018W8, Exp. Oct-11
        54018W9, Exp. Oct-11
        540197P, Exp. Nov-11
        54019NN, Exp. Jan-12
        5401C9X, Exp. Feb-12

    • LLOYD Laboratories (VetaKet)

      • 6091572, Exp. Sep-09
        6111903, Exp. Nov-09
        7010001, Exp. Jan-10
        540186J, Exp. Sep-11

    • Phoenix (Ketaject)

      • 6101617, Exp. Oct-09
        6111887, Exp. Nov-09
        6121972, Exp Dec-09
        6121994, Exp. Dec-09
        6122045, Exp. Dec-09
        7010043, Exp. Jan-10
        7010101, Exp. Jan-10
        7010148, Exp. Jan-10
        7020267, Exp. Feb-10
        7030369, Exp. Mar-10
        7050706, Exp. May-10
        7060835, Exp. Jun-10
        7081091, Exp. Aug-10

    • RXV (Keta-Sthetic)

      • 6121972, Exp. Dec-09
        6121994, Exp. Dec-09
        7050706, Exp. May-10

    • VEDCO (KetaVed)

      • 6101617, Exp. Oct-09
        6111887, Exp. Nov-09
        6121972, Exp Dec-09
        6122045, Exp. Dec-09
        7010043, Exp. Jan-10
        7010101, Exp. Jan-10
        7010148, Exp. Jan-10
        7020267, Exp. Feb-10
        7030369, Exp. Mar-10
        7050706, Exp. May-10
        7060835, Exp. Jun-10
        7070963, Exp. Jul-10
        540186J, Exp. Sep-11
        540186K, Exp. Sep-11
        5401G4V, Exp. Feb-12

  • 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 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.

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

Butorphanol Tartrate Injections Recalled at the Distributor Level in September

In addition to this customer-level recall of ketamine, several butorphanol products manufactured by Teva Animal Health, Inc. were recalled as a precautionary measure at the distributor level in September 2009.

The products recalled included: Equanol (Vedco), ButorJect (Phoenix), TorphaJect (Butler).

According to Teva  and the FDA CVM, there has been no increased trend of adverse event reports associated with the use of these butorphanol products that would justify further action beyond the initial precautionary recall in September.

Published: January 5, 2010;    Updated: May 4, 2010

Filed Under: Recalls Warnings

Sources: FDA, AVMA

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