FDA: Company voluntarily recalls injectable versions of popular NSAIDs
A pharmaceutical company in the UK is voluntarily recalling 34 lots of commonly used veterinary injectable drug products due to sterility concerns, according to the FDA.
Norbrook Laboratories in Newry, Northern Ireland, issued the recall May 24, saying that although some of its products tested, released, and distributed within the US were manufactured on an aseptic line, they failed to pass subsequent aseptic process simulation tests. The company said that if the sterility of these drugs has been compromised, using them could introduce infectious agents to the animals.
The company first reported possible sterility concerns in early March of this year.
The company notes that, “Intravenous administration of nonsterile drugs is especially concerning due to the risk of rapid systemic dissemination of infectious agents, which could result in sepsis of the animal and death.”
This may result in the need for medical interventions, including, but not limited to, the need for supportive care, antibiotics, and/or antifungal drugs.
Although most of the drugs on the recall list are intended for livestock, some are formulated for use in companion animals.
The recalled drugs include the following nonsteroidal anti-inflammatory drugs (NSAIDs): Carprieve Injection, CarproJect Injection, Levafen Injection, and OstiFen Injection (carprofen; 50 mg/mL), all of which are 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.
Other injectable NSAIDs on the recall list include Loxicom Injection, EloxiJect Injection, and OstiLox Injection (meloxicam; 5 mg/mL), all used for the relief of pain and inflammation associated with orthopedic surgery, ovariohysterectomy, and castration in dogs and cats.
The recalled products were distributed nationwide in the USA to Norbrook’s wholesale distributors. Norbrook is notifying its distributors by phone and in writing to immediately discontinue distribution of the specific lots being recalled and to notify their subaccounts.
NEWStat reached out to Joshua Bub, DVM, DABVP, a task force member on AAHA’s Infection Control, Prevention, and Biosecurity Guidelines, to ask how serious the threat is and what hospitals should do about it.
Bub pointed out that the company statement published by the FDA said that the line these drugs were manufactured on did not pass process simulation tests: “This is different [from] saying there were infectious organisms discovered in the vials. However, if an injection were to be given and there were infectious organisms [present], this could present a risk for local infection, abscess [and], sepsis—especially if given intravenously.”
“So regardless of how likely a risk, the consequences are serious and warrant action,” Bub added.
Bub said practices should go through their shelves and pull out any products that match the lots listed in the FDA recall. “Contact your distributor if you have these products and get a refund. Don’t use them or you can be putting your patients and your license at risk.”
A complete list of the recalled product is posted on the FDA website
“Other manufacturers have these drugs,” Bub said. “Reach out to your suppliers and get drugs from another manufacturer until this issue is resolved.”
Contact Norbrook Laboratories at 1-866-591-5777 Monday through Friday from 9:00 a.m. to 5:00 p.m. CST.