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| The United States: Norbrook Laboratories Limited recalls veterinary products for health risk (English Only) |
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The US Food and Drug Administration (FDA) announces that Norbrook Laboratories Limited of Newry, Northern Ireland is recalling two lots of Enroflox® 100 Injection (enrofloxacin), two lots of Noromectin® Injection (ivermectin) and two lots of Ivermax® 1% Injection (ivermectin) 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. The affected products are:
- Enroflox 100 (100 mg/mL; 100 mL vial): lot number: 826390A; expiry date: Jun 2021
- Enroflox 100 (100 mg/mL; 500 mL vial): lot number: 830192A; expiry date: Jul 2020
- Noromectin Injection (10 mg/mL; 250 mL vial): lot number: 831591A; expiry date: Aug 2021
- Noromectin Injection (10 mg/mL; 1000 mL vial): lot number: 834491A; expiry date: Aug 2021
- Ivermax 1% Injection (10 mg/mL; 250 mL vial): lot number: 831591B; expiry date: Aug 2021
- Ivermax 1% Injection (10 mg/mL; 1000 mL vial): lot number: 831590A; expiry date: Aug 2021
Norbrook Laboratories Limited 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, Norbrook Laboratories Limited has not received any reports of adverse events related to this recall. The products were distributed nationwide to Norbrook’s wholesale distributors.
Please refer to the following website in FDA for details:
http://www.fda.gov/Safety/Recalls/ucm632955.htm
In Hong Kong, the above products are not registered pharmaceutical products.
Ends/Friday, Mar 8, 2019
Issued at HKT 16:00
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