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RECALL ALERT: Norbrook Laboratories Recalling 34 Lots of Injectable Drugs

Norbrook Laboratories is recalling 34 lots of veterinary injectable drug products to the veterinarian/consumer level as a precautionary measure as product sterility cannot be assured. There is a concern that if the sterility of these products has been compromised, use of these products could result in introduction of infectious agents to the animal.

This may result in the need for medical intervention(s) including, but not limited to the need for supportive care, antibiotics, and/or antifungal drugs. Intravenous administration of non-sterile 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.

recall

Norbrook Laboratories Limited discovered that product tested, released and distributed within the USA was manufactured on an aseptic line that subsequently did not pass process simulation tests. Norbrook places the utmost emphasis on safety and product quality at every step in the manufacturing and supply chain process. Although the possibility of a breach in sterility assurance in distributed product cannot be eliminated, no batches of product have been identified as containing microorganisms.

Among the 34 products recalled, several were sold and distributed for use in dogs or cats, including:

Carprieve® Injection, CarproJect™ Injection, Levafen™ Injection and OstiFen™ Injection (carprofen; 50 mg/mL) are a non-steroidal anti-inflammatory drug (NSAID) 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 a non-steroidal anti-inflammatory drug (NSAID) 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 product lots subject to recall are listed below. The product can be identified by checking the product name, manufacturer details and lot number on the carton or vial.

NDCProduct NamePackage SizeLot NumberExpiry Date
55529-152-02Enroflox 100100 mL vial9075-90AFeb 2022
55529-011-01Noromectin Plus Injection50 mL vial9065-90AFeb 2022
55529-014-02300 PRO LA100 mL vial9063-90BFeb 2022
55529-015-02Noromycin 300 LA100 mL vial9063-90AFeb 2022
55529-004-02Oxytetracycline Injection 200 100 mL vial9071-94CFeb 2022
55529-004-02Oxytetracycline Injection 200100 mL vial9071-94DFeb 2022
55529-004-02Oxytetracycline Injection 200100 mL vial9071-94EFeb 2022
46066-007-02Terra-Vet 200100 mL vial9071-94BFeb 2022
30798-237-10Duramycin 72-200100 mL vial9071-94AFeb 2022
55529-006-02Flunixin Injection100 mL vial9092-91BFeb 2022
13985-018-02Prevail Injection100 mL vial9092-91CFeb 2022
46066-008-02Vetameg100 mL vial9092-91AFeb 2022
55529-030-02Flunixin Injection –S100 mL vial9092-91DFeb 2022
55529-131-11Carprieve Injection20 mL vial9035-90CJan 2021
11695-6934-1CarproJect Injection20 mL vial9035-90BJan 2021
11695-6934-1CarproJect Injection20 mL vial9084-91CFeb 2021
14043-908-20Levafen Injection20 mL vial9035-90DJan 2021
14043-908-20Levafen Injection20 mL vial9084-91BFeb 2021
14043-908-50Levafen Injection50 mL vial9035-91AJan 2021
13985-748-20OstiFen Injection20 mL vial9035-90AJan 2021
13985-748-20OstiFen Injection20 mL vial9084-91AFeb 2021
55529-040-11Loxicom Injection20 mL vial9102-92AMar 2022
11695-6925-1EloxiJect Injection10 mL vial9102-91DMar 2022
11695-6925-2EloxiJect Injection20 mL vial9102-92BMar 2022
13985-559-10OstiLox Injection10 mL vial9102-91AMar 2022
13985-559-20OstiLox Injection20 mL vial9102-92CMar 2022
55529-154-02Enroflox Injection for Dogs 2.27%100 mL vial9034-92AJan 2021
55529-154-01Enroflox Injection for Dogs 2.27%50 mL vial9034-91BJan 2021
55529-154-11Enroflox Injection for Dogs 2.27%20 mL vial9034-90AJan 2021
55529-154-11Enroflox Injection for Dogs 2.27%20 mL vial9083-93AFeb 2021
13985-709-20Enrosite Injection for Dogs 2.27%20 mL vial9034-90BJan 2021
13985-709-20Enrosite Injection for Dogs 2.27%20 mL vial9034-90CJan 2021
13985-709-20Enrosite Injection for Dogs 2.27%20 mL vial9083-93BFeb 2021
13985-709-50Enrosite Injection for Dogs 2.27%50 mL vial9034-91AJan 2021

These injectable drug products were distributed nationwide in the USA to Norbrook’s wholesale distributors. Norbrook Laboratories Limited is notifying its distributors by phone and in writing to immediately discontinue distribution of the specific lots being recalled and to notify their sub-accounts. Norbrook is arranging for return of all recalled products to the veterinarian/consumer level for a full refund. Instructions for returning recalled products are provided in the recall letter.

The FDA’s Center for Veterinary Medicine recommends calling the drug company to report adverse drug experiences or product defects for FDA-approved animal products. The drug company responsible for the approved product is required to submit these reports to FDA. Contact Norbrook Laboratories Limited at 1-866-591-5777 Monday through Friday 9 am – 5 pm CST.

If you prefer to report directly to the FDA, you can submit Form FDA 1932a by following the link to the form found at https://www.fda.gov/AnimalVeterinary/SafetyHealth/ReportaProblem/ucm055305.htmand following the instructions for emailing the completed form to FDA.

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration (FDA).

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