Norbrook Laboratories Limited of Newry, Northern Ireland is expanding the recall of subcutaneous injectable drug products that began in early March 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.
As initially reported in early March 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.