Norbrook recalls veterinary products due to potential break in sterility

May 28, 2019

The 34 recalled products are labeled for use in both small and large animals.

Norbrook Laboratories Ltd. (based in Newry, UK) announced Friday that it's recalling 34 lots of veterinary injectable drug products as a precautionary measure because product sterility cannot be guaranteed.

According to a company release, Norbrook discovered that product tested, released and distributed within the United States was manufactured on an aseptic line that subsequently did not pass process simulation tests. To date, however, no microorganisms have been identified in any of the product batches.

A break in sterility of these products could introduce infectious agents to the animal, possibly necessitating such medical interventions as supportive care, antibiotics or antifungal drugs. Intravenous administration of nonsterile drugs is especially concerning due to the risk of rapid systemic dissemination of infectious agents, which could result in sepsis and death, the release states.

The recalled products were distributed to Norbrook's wholesale distributors throughout the United States. Norbrook is notifying its distributors by phone and in writing to discontinue distribution of the recalled lots and to notify their subaccounts immediately. The company is arranging for return of all recalled products for a full refund.

The small animal-specific recalled products are listed below. For a full list of affected products, including those for cattle, horses and swine, click here.

> Carprieve Injection, CarproJect Injection, Levafen Injection and OstiFen Injection (carprofen; 50 mg/mL) are nonsteroidal anti-inflammatory drugs (NSAIDs) used for the relief of pain and inflammation associated with osteoarthritis and control of postoperative pain associated with soft tissue and orthopedic surgeries in dogs.

> Loxicom Injection, EloxiJect Injection and OstiLox Injection (meloxicam; 5 mg/mL) are NSAIDs used for the relief of pain and inflammation associated with orthopedic surgery, ovariohysterectomy and castration in dogs and cats.

> Enroflox Injection for Dogs 2.27% and EnroSite Injection for Dogs 2.27% (enrofloxacin; 22.7 mg/mL) are indicated for the management of diseases in dogs associated with bacteria susceptible to enrofloxacin.

The FDA's Center for Veterinary Medicine (CVM) recommends calling the company to report adverse drug experiences or product defects for FDA-approved animal products. The company is then required to submit these reports to FDA. Contact Norbrook Laboratories at 866-591-5777 Monday through Friday 9 a.m. to 5 p.m. CST.

Individuals may also report adverse events directly to the FDA through Form FDA 1932a. For questions about adverse drug event reporting or to acquire a paper copy of Form 1932a, contact the CVM by email at AskCVM@fda.hhs.gov or by phone at 888-FDA-VETS (888-332-8387).