Norbrook Laboratories Limited recalls veterinary products to provide sterility assurance | Food and Drug Administration

2021-12-08 11:03:05 By : Mr. Jason Huang

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Norbrook Laboratories Limited of Newry, United Kingdom recalled 34 batches of veterinary injectable drugs to the veterinary/consumer level as a preventive measure because the sterility of the products cannot be guaranteed. There is concern that if the sterility of these products is compromised, the use of these products may lead to the introduction of infectious sources into animals. This may result in the need for medical intervention, including but not limited to the need for supportive care, antibiotics and/or antifungal drugs. The intravenous administration of non-sterile drugs is particularly worrying because of the risk of rapid systemic transmission of infectious agents, which may lead to animal sepsis and death.

Norbrook Laboratories Limited found that the products tested, released and distributed in the United States were produced on an aseptic production line and subsequently failed the process simulation test. Norbrook attaches great importance to safety and product quality at every step of the manufacturing and supply chain process. Although it is impossible to eliminate the possibility of violating sterility guarantees in distributed products, it has not been determined that any batches of products contain microorganisms.

Enroflox® 100 injection (enrofloxacin; 100 mg/mL) is an antibacterial agent used to treat and control bovine respiratory diseases, treat and control swine respiratory diseases, and control porcine colibacillosis.

Noromectin® Plus injection (ivermectin; 10 mg/ml and chlorsulfuron; 100 mg/ml) is a parasiticide used to treat and control internal and external parasites in cattle.

300 PRO LA and Noromycin® 300 LA (Orytetracycline; 300 mg/mL) are broad-spectrum antibiotics used to treat various diseases caused by sensitive gram-positive and gram-negative bacteria in non-lactating beef cattle Cows, calves and pigs.

Oxytetracycline Injection 200, Terra-Vet 200 and Duramycin 72-200 (oxytetracycline; 200 mg/mL) are broad-spectrum antibiotics used in beef cattle, dairy cattle, calves and pigs.

Flunixin Injection, Prevail™ and Vetameg™ (flunixin meglumine; 50 mg/mL) are non-steroidal analgesics with anti-inflammatory and antipyretic activities and are used in horses and cattle.

Flunixin Injection -S (flunixin meglumine; 50 mg/mL) is a non-steroidal analgesic with anti-inflammatory and antipyretic activity for pigs.

Carprieve® injection, CarproJect™ injection, Levafen™ injection, and OstiFen™ injection (Carprofen; 50 mg/ml) are a non-steroidal anti-inflammatory drug (NSAID) used to relieve osteoarthritis related It also controls the pain and inflammation associated with the dog’s soft tissue and orthopedic surgery after surgery.

Loxicom® injection, EloxiJect™ injection, and OstiLox™ injection (meloxicam; 5 mg/ml) are a non-steroidal anti-inflammatory drug (NSAID) used to relieve orthopedic surgery and ovarian hysterectomy in dogs Pain and inflammation associated with surgery and castration. cat.

Enroflox® Injection for Dogs 2.27% and EnroSite™ Injection for Dogs 2.27% (enrofloxacin; 22.7 mg/mL) are suitable for the treatment of diseases related to enrofloxacin-sensitive bacteria in dogs.

The batches of products that need to be recalled are listed below. The product can be identified by checking the product name, manufacturer details, and batch number on the carton or vial.

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

The FDA Veterinary Center recommends calling pharmaceutical companies to report adverse drug experiences or product defects in FDA-approved animal products. The pharmaceutical company responsible for approving the product needs to submit these reports to the FDA. Monday to Friday, 9 am to 5 pm Central Standard Time, please call Norbrook Laboratories Limited at 1-866-591-5777.

If you prefer to report directly to the FDA, you can click on the link to the form at and follow the e-mail instructions to submit the completed FDA 1932a form. To the FDA.

If you have questions about the ADE report or need a paper copy of the form, please email or call 1-888-FDA-VETS (1-888-332-8387) to contact CVM.

The recall was carried out with the knowledge of the U.S. Food and Drug Administration (FDA).

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