In July 2009 the FDA shut down Teva Animal Health Inc., preventing them from manufacturing and distributing Veterinary drugs due to non-compliance issues discovered during multiple inspections between 2007 and 2009. One report from 2009 indicates multiple violations including: lots of drugs in which particles were found, lots of tablets with appearance issues and unexplained spots, colored tablets that were supposed to be color-less, foreign material floating in the product, defective and overweight tablets, non-sterile water used to formulate drugs, failure to reject lots where the previous problems were present, failure to maintain equipment, and failure of quality standards and procedures.

Just prior to the shut down Teva had issued a voluntary recall of Propofol Injectible Emulsion (propofol is a variety of anesthetic commonly used for surgery in pets). The release states the reason as “due to the presence of elevated endotoxin levels in some vials” and further details of “41 propofol-treated patients who experienced post-operative fever, chills and other flu-like symptoms” which are symptoms of elevated levels of endotoxins along with other more serious effects.

On September 4th, 2009 a letter of recall was sent to Teva’s distributors which included a list that was three pages long detailing lots of Ketamine Hydrachloride Injection (another commonly used anesthetic in pet surgery) and Butorphanol Tartrate Injection (an opiod used to control pain during surgery) distributed under various private label trade names that were implicated in the recall. The letter simply states that, “While there is no data indicating the products do not meet finished product specifications throughout their shelf life, there is inconsistent and potentially incomplete documentation to support these products were developed, manufactured, controlled and tested in substantial compliance with Good Manufacturing Practices.” The letter implicates the following products in the distributor recall:

Ketamine
-Ketaset (Fort Dodge/Pfizer)
-KetaVed (VEDCO), KetaThesia (Butler)
-VetaKet (LLOYD Laboratories)
-Ketaject (Phoenix)
-Keta-Sthetic (RVX)
-AmTech Group, Inc.

Butorphanol
-EQUANOL (VEDCO)
-ButorJect (Phoenix)
-TorphaJect (Butler)

Since this letter was sent only to distributors who were not required to notify Vets, most Veterinarians and pet owners were unaware of the recall until December when…

On December 21, 2009 the voluntary recall of Ketamine Hydrochloride Injection was finally made public to include “all lot numbers within their expiration dates” due to “an increased trend in serious adverse events associated with this product.” Notice that there is still no mention of the Butorphanol recall, only the Ketamine. Apparently the “serious adverse events” that led to the FDA announcement included the death of five cats. Note, the FDA announcement linked to above has already been modified as an “expanded” recall from a later notice…see below.

On December 29, 2009 more information on the recall was released including the fact that the recall was not just limited to Ketamine manufactured by Teva, but also the that sold under various big brand names including Ketaset (Fort Dodge/Pfizer), KetaVed (VEDCO), KetaThesia (Butler), VetaKet (LLOYD Laboratories), Ketaject (Phoenix), Keta-Sthetic (RVX),and AmTech Group, Inc. Of course you can see this information on that distributor letter from back in September, but this was the first time the information was made public.

So what is the big deal here? Other than the fact that the recall was not made public immediately so that any affected items could be returned, but instead continued being used for an additional three months or more… The recalled Ketamine is suspected to have distributed to Veterinarians as early as 2006, so these products which have now been linked to questionable deaths have been in use for three years. In addition, the Butorphanol recall still has not been made public beyond a distributor level except ‘accidentally’ with the uncovered distributor letter that detailed the original recall from Teva. A note on the AVMA website dated 1.14.10 states:

“Butorphanol is not affected by the expanded ketamine recall. Several butorphanol products manufactured by Teva Animal Health, Inc. were recalled as a precautionary measure at the distributor level in September 2009. Neither Teva Animal Health, Inc. nor the FDA Center for Veterinary Medicine has observed an increasing 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.”

This recall is starting to have a distinct stink similar to the 2007 pet food recall debacle…so stay tuned.

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