(KPLC) - Norbrook Laboratories Limited is recalling two lots of Enroflox® 100 Injection, two lots of Noromectin® Injection and two lots of Ivermax® 1% Injection to the veterinarian/consumer level as a precautionary measure as product sterility cannot be assured, the FDA says.
According to the FDA, if the sterility has been compromised, use of these products could result in introduction of infectious agents to the animal. The product was potentially manufactured on an aseptic line that subsequently did not pass process simulation tests.
Enroflox® 100 Injection is an antimicrobial used for the treatment and control of bovine respiratory disease and for the treatment and control of swine respiratory disease, FDA says. Noromectin® Injection is a parasiticide used for the treatment and control of internal and external parasites in cattle and swine.
Here are the affected products:
- 55529-152-02 - Enroflox 100 (100 mg/mL; 100 mL vial) - 826390A - Jun 2021
- 55529-152-05 - Enroflox 100 (100 mg/mL; 500 mL vial) - 830192A - Jul 2020
- 55529-012-04 - Noromectin Injection (10 mg/mL; 250 mL vial) - 831591A - Aug 2021
- 55529-012-06 - Noromectin Injection (10 mg/mL; 1000 mL vial) - 834491A - Aug 2021
- 46066-917-04 - Ivermax 1% Injection (10 mg/mL; 250 mL vial) - 831591B - Aug 2021
- 46066-917-06 - Ivermax 1% Injection (10 mg/mL; 1000 mL vial) - 831590A - Aug 2021
These products were distributed nationwide, FDA says. No adverse events have been reported.
The company has arranged for return of all recalled products for a full refund. See the full report HERE.