Norbrook Laboratories Limited Recalls Veterinary Products for Health Risk

COMPANY ANNOUNCEMENT

Summary

• Company Announcement Date: March 07, 2019
• FDA Publish Date: March 07, 2019
• Product Type: Animal & Veterinary ; Animal Drugs
• Reason for Announcement: Lack of sterility assurance
• Company Name: Norbrook Laboratories Limited
• Brand Name: Norbrook
• Product Description: Enroflox® 100 Injection, Noromectin® Injection, Ivermax® 1% Injection

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Company Announcement

March 7, 2019, 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.

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. To date, Norbrook Laboratories Limited has not received any reports of adverse events related to this recall.

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.

Noromectin® Injection is a parasiticide used for the treatment and control of internal and external parasites in cattle and swine.

The products subject to recall are listed below. The product can be identified by checking the product name, manufacturer details and lot number on the carton or vial.

NDC	Product Name, Strength and Package Size	Lot Number	Expiry Date
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

Enroflox® 100 Injection, Noromectin® Injection and Ivermax® 1% Injection were distributed nationwide to Norbrook’s wholesale distributors. Norbrook Laboratories Limited is notifying its distributors by phone and in writing to immediately discontinue distribution of the specific lots being recalled and to notify their sub-accounts. Norbrook is arranging for return of all recalled products to the veterinarian/consumer level for a full refund. Instructions for returning recalled products are provided in the recall letter.

The Center for Veterinary Medicine recommends calling the drug company to report adverse drug experiences or product defects for FDA-approved animal products. The drug company responsible for the approved product is required to submit these reports to FDA. Contact Norbrook Laboratories Limited at 1-866-591-5777 Monday through Friday 9 am – 5 pm CST.

If you prefer to report directly to the FDA, you can submit Form FDA 1932a by following the link to the form found at https://www.fda.gov/AnimalVeterinary/SafetyHealth/ReportaProblem/ucm055305.htm and following the instructions for emailing the completed form to FDA.

If you have a question about ADE reporting or need a paper copy of the form, contact CVM by email at AskCVM@fda.hhs.gov or by phone at 1-888-FDA-VETS (1-888-332-8387).

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration (FDA).

Expanded Press Release

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Company Contact Information

• Consumers: Norbrook Laboratories Limited ; 1-866-591-5777