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. http://www.fda.gov/Safety/Recalls/ucm195118.htm

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.

http://news.vin.com/VINNews.aspx?articleId=14720

To learn more about onsite pharmaceutical material screening solutions, visit: www.xstreamsystems.net.

EPA Investigating Adverse Reactions to Flea and Tick Products

An increase in reports of adverse reactions among pets to topical flea and tick medicines has prompted the Environmental Protection Agency (EPA) to intensify its scrutiny of these products. The products have not been recalled, but the agency is warning pet owners that the treatments may have serious, even fatal, side effects.

This investigation, according to the EPA, is due to some 44,000 complaints over the past year that the EPA has received from consumers. This represents a 53% increase over the previous year. Approximately 1,200 of those reports accounted for animal deaths.

Spot-on flea and tick treatments are applied topically, usually between the animal’s shoulder blades or along the spine. A majority of products being investigated appear to be Over-the-Counter (OTC) products rather than those obtained through a veterinarian. A list of more than 200 brands of registered products appear on EPA’s website.

According to agency spokesman Dale Kemery, the adverse reactions included skin irritations, hair loss and tremors. The E.P.A.’s report on liquid flea and tick treatments is expected by October and will be published on the agency’s Web site.

The appearance of counterfeit pesticide products for dogs and cats has further complicated the picture. On April 28, the E.P.A. warned distributors and retailers to stop selling counterfeit products with the brand names Advantage and Frontline, and to recall those already sold.

Consumers may call the National Pesticide Information Center at (800) 858-7378 to report a problem with the products. The agency has also advised veterinarians to report adverse reactions at the center’s Veterinary Pesticide Adverse Effects reporting portal.

To view registered products list visit EPA website at: www.epa.gov

To view more information on counterfeit Advantage and Frontline, visit: www.epa.gov

For the Veterinary Pesticide Adverse Effects reporting portal visit: http://pi.ace.orst.edu/vetrep/

Compounded Drug Responsible for the 21 Horse Deaths

A Florida pharmacy announced that an ingredient in a drug which they compounded was responsible for the deaths of the 21 polo horses from a Venezuelan polo team that died Sunday at the U.S. Open Polo Tournament in Wellington, Florida.

Fourteen of the horses died while on the field prior to the scheduled match while another seven horses died while in transit to an equine hospital for treatment.

The Florida Department of Agriculture and various other regulatory agencies are performing necropsies and blood tests on the animals. The agencies expect to announce their findings shortly.

Franck's Pharmacy in Ocala revealed that a lawyer it hired to investigate the case concluded one ingredient was off during the mixing process.

"The strength of an ingredient in the medication was incorrect," said Jennifer Beckett, of Franck's Pharmacy. "We will cooperate fully with the authorities as they continue their investigation." She declined to answer questions but offered condolences to the team: "We share their grief and sadness."

The pharmacy was compounding a drug similar to Biodyl, a drug that is not FDA approved or available in the United States. Biodyl described as a vitamin supplement for livestock is used primarily in animals that are engaged in sporting activities or following transport to assist them in their performance or recovery.

This tragedy again strengthens the case for authentication and verification of both the materials used as ingredients and the end use medications for both human and animal consumption. Similar to the adulterated raw material used to produce the Heparin that killed nearly 250 in the United States last year; this incident demonstrates the vulnerability of the United States pharmaceutical supply chain which includes production, distribution and dispensing. Suspicion is now centering on the raw materials that were used in the compounded drugs and the source of supply of these ingredients.

Tainted Drugs Kill 21 Horses in Florida

(Details Developing)

Various news sources, including the South Florida Sun Sentinel, are reporting that as many as 21 horses have died after receiving injections of a drug from an Argentine Veterinarian. It is believed that shots from the veterinarian, who is not licensed in the United States, may have been tainted with some sort of toxic agent.

The horses, or pedigreed polo ponies, belonged to a single Venezuelan team competing in the U.S. Open Polo Tournament at the Palm Beach Polo Club in Wellington, Florida. Each of the horses is estimated to be valued in excess of $100,000.

Fourteen of the horses collapsed on the polo grounds before the start of their scheduled match and seven others died at or while in route to an equine animal hospital several hours later. Efforts to treat the horses at the polo grounds and the hospital were unsuccessful.

The story and details are still developing but Florida officials are conducting necropsies and blood analysis on the animals to determine what specifically caused their death.

It still remains to be determined if the drugs that were injected were legal in the US, where they came from and the source of contamination of the drug.

This tragedy seems to be a harbinger of concern as it relates to medication and product safety for both animals and humans in the United States. The issue of counterfeit, adulterated and tainted medications worldwide continue to kill and injure hundreds of thousands of people and animals annually and now appears to be poised to significantly impact the population here in the United States. There is little distinction between human and animal medications as it relates to the production of pharmaceuticals, any issue that impacts one group of consumers will ultimate impact the other.

XStream believes that materials analysis of all medications within the supply chain (production, distribution and dispensing) is vital as it relates protecting all health care consumers from counterfeit, adulterated and contaminated medications.