Norbrook Laboratories voluntarily recalls veterinary injectable drug productsMay 30, 2019Norbrook Laboratories is recalling 34 lots of veterinary injectable drug products over concerns related to sterility assurance. The U.K.-based company says products tested, released, and distributed within the U.S. were manufactured on an aseptic line, which did not pass process simulation tests. The recall was made as a precautionary measure, as according to Norbrook, no batches of product have been identified to contain microorganisms. The following products have been recalled: Carprieve Injection, CarproJect Injection, Levafen Injection, and OstiFen Injection (carprofen; 50 mg/mL). They are nonsteroidal anti-inflammatory drugs (NSAIDs) for the pain and inflammation relief 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 connected 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 used for the management of diseases in dogs associated with bacteria susceptible to enrofloxacin Enroflox 100 Injection (enrofloxacin; 100 mg/mL) is an antimicrobial used for the treatment and control of bovine respiratory disease, for the treatment and control of swine respiratory disease, …
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FDA warns against using possible nonsterile animal drug productsJuly 12, 2018The U.S. Food and Drug Administration is alerting veterinarians and animal owners to not use animal drug products labeled as sterile produced and distributed by Ranier's Compounding Laboratory "due to a lack of sterility assurance." Jeannette, Pa.-based Ranier's also does business as Ranier's Pharmacy and Ranier's RX Laboratory. The FDA is urging veterinarians to check their inventory, quarantine any purportedly sterile drug products, and not administer them to patients. Administration of a nonsterile drug product intended to be sterile may result in serious and potentially life-threatening infections or death, according to the report. FDA issued a warning letter to Ranier's Compounding in March 2017 following an inspection. During FDA's recent follow-up inspection of Ranier's compounding facility, investigators observed insanitary conditions, including poor sterile production practices. On June 6, 2018, FDA recommended that Ranier's Compounding recall all unexpired human and animal drug products intended to be sterile and to cease sterile operations until it makes adequate corrections at its facility. On June 7, 2018, Ranier's Pharmacy informed FDA that it agreed to voluntarily recall and cease sterile operations. However, the company has failed to comply with its commitment, reported the FDA. To date, no …
