Medicine recalls
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| The United States: Norbrook Laboratories Limited expands recall of veterinary products |
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The US Food and Drug Administration (FDA) announces that Norbrook Laboratories Limited of Newry, Northern Ireland is expanding the recall of subcutaneous injectable drug products that began in early Mar 2019. Norbrook is adding to the recall four lots of Enroflox® 100 Injection (enrofloxacin), two lots of Noromectin® Injection (ivermectin) and one lot 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: 824190A; expiry date: Jun 2021
- Enroflox 100 (100 mg/mL; 250 mL vial): lot number: 824290A; expiry date: Jun 2021
- Enroflox 100 (100 mg/mL; 250 mL vial): lot number: 828392A; expiry date: Jun 2021
- Enroflox 100 (100 mg/mL; 500 mL vial): lot number: 830193A; expiry date: Jul 2020
- Noromectin Injection (10 mg/mL; 50 mL vial): lot number: 834595B; expiry date: Aug 2021
- Noromectin Injection (10 mg/mL; 1000 mL vial): lot number: 834596A; expiry date: Aug 2021
- Ivermax 1% Injection (10 mg/mL; 50 mL vial): lot number: 834595A; expiry date: Aug 2021
As initially reported in early Mar 2019, 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.
Please refer to the following website in FDA for details:
http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/norbrook-laboratories-limited-expands-recall-veterinary-products
In Hong Kong, the above products are not registered pharmaceutical products. Related news was previously issued by FDA, and was posted on the Drug Office website on 8 Mar 2019.
Ends/Friday, May 10, 2019
Issued at HKT 15:00
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