Norbrook Laboratories Limited Expands Recall of Veterinary Products, to include Enroflox® 100
Injection (enrofloxacin), two lots of Noromectin® Injection (ivermectin)
and one lot of Ivermax® 1% Injection (ivermectin)
Summary
- Company Announcement Date:
- April 29, 2019
- FDA Publish Date:
- April 29, 2019
- Product Type:
- Animal & Veterinary
Animal Drugs - Reason for Announcement:
- Device & Drug Safety, Potential Lack of Sterility
- Company Name:
- Norbrook Laboratories Limited
- Brand Name:
- Norbrook Laboratories Limited
- Product Description:
- Subcutaneous injectable drug products
Company Announcement
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.
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.
Ivermax® 1% Injection is a parasiticide used for the treatment and control of gastrointestinal roundworms, lungworms, lice, and mange mites 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) | 824190A | Jun 2021 |
| 55529-152-04 | Enroflox 100 (100 mg/mL; 250 mL vial) | 824290A | Jun 2021 |
| 55529-152-04 | Enroflox 100 (100 mg/mL; 250 mL vial) | 828392A | Jun 2021 |
| 55529-152-05 | Enroflox 100 (100 mg/mL; 500 mL vial) | 830193A | Jul 2020 |
| 55529-012-01 | Noromectin Injection (10 mg/mL; 50 mL vial) | 834595B | Aug 2021 |
| 55529-012-06 | Noromectin Injection (10 mg/mL; 1000 mL vial) | 834596A | Aug 2021 |
| 46066-917-01 | Ivermax 1% Injection (10 mg/mL; 50 mL vial) | 834595A | 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.htmand 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).
Company Contact Information
- Consumers:
- Norbrook Laboratories Limited
- 866-591-5777
No comments:
Post a Comment