Norbrook Laboratories Limited Recalls Veterinary Products to Provide Sterility Assurance
Summary
- Company Announcement Date:
- May 24, 2019
- FDA Publish Date:
- May 24, 2019
- Product Type:
- Animal & Veterinary
Generic Animal Drugs - Reason for Announcement:
- Product sterility cannot be assured
- Company Name:
- Norbrook Laboratories Limited
- Brand Name:
- Norbrook
- Product Description:
- Veterinary injectable drug products
Company Announcement
Norbrook Laboratories Limited of Newry, United Kingdom is recalling 34 lots of veterinary injectable drug products 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. Intravenous administration of non-sterile drugs is especially concerning, due to the risk of rapid systemic dissemination of infectious agents, which could result in sepsis of the animal and death.
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. Norbrook places the utmost emphasis on safety and product quality at every step in the manufacturing and supply chain process. Although the possibility of a breach in sterility assurance in distributed product cannot be eliminated, no batches of product have been identified as containing microorganisms.
Enroflox® 100 Injection (enrofloxacin; 100 mg/mL) is an antimicrobial used for the treatment and control of bovine respiratory disease, for the treatment and control of swine respiratory disease, and for the control of Colibacillosis in swine.
Noromectin® Plus Injection (ivermectin; 10 mg/mL and clorsulon; 100 mg/mL) is a parasiticide used for the treatment and control of internal and external parasites in cattle.
300 PRO LA and Noromycin® 300 LA (oxytetracycline; 300 mg/mL) is a broad-spectrum antibiotic used for the treatment of a wide range of diseases caused by susceptible gram-positive and gram-negative bacteria in beef cattle, non-lactating dairy cattle, calves and swine.
Oxytetracycline Injection 200, Terra-Vet 200 and Duramycin 72-200 (oxytetracycline; 200 mg/mL) are a broad-spectrum antibiotic for use in beef cattle, dairy cattle, calves and swine.
Flunixin Injection, Prevail™ and Vetameg™ (flunixin meglumine; 50 mg/mL) are a non-steroidal analgesic agent with anti-inflammatory and anti-pyretic activity for use in horses and cattle.
Flunixin Injection -S (flunixin meglumine; 50 mg/mL) is a non-steroidal analgesic agent with anti-inflammatory and anti-pyretic activity for use in swine.
Carprieve® Injection, CarproJect™ Injection, Levafen™ Injection and OstiFen™ Injection (carprofen; 50 mg/mL) are a non-steroidal anti-inflammatory drug (NSAID) used for the relief of pain and inflammation associated with osteoarthritis and control of postoperative pain associated with soft tissue and orthopedic surgeries in dogs.
Loxicom® Injection, EloxiJect™ Injection and OstiLox™ Injection (meloxicam; 5 mg/mL) are a non-steroidal anti-inflammatory drug (NSAID) used for the relief of pain and inflammation associated with orthopedic surgery, ovariohysterectomy and castration in dogs and cats.
Enroflox® Injection for Dogs 2.27% and EnroSite™ Injection for Dogs 2.27% (enrofloxacin; 22.7 mg/mL) are indicated for the management of diseases in dogs associated with bacteria susceptible to enrofloxacin.
The product lots 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 | Package Size | Lot Number | Expiry Date |
|---|---|---|---|---|
| 55529-152-02 | Enroflox 100 | 100 mL vial | 9075-90A | Feb 2022 |
| 55529-011-01 | Noromectin Plus Injection | 50 mL vial | 9065-90A | Feb 2022 |
| 55529-014-02 | 300 PRO LA | 100 mL vial | 9063-90B | Feb 2022 |
| 55529-015-02 | Noromycin 300 LA | 100 mL vial | 9063-90A | Feb 2022 |
| 55529-004-02 | Oxytetracycline Injection 200 | 100 mL vial | 9071-94C | Feb 2022 |
| 55529-004-02 | Oxytetracycline Injection 200 | 100 mL vial | 9071-94D | Feb 2022 |
| 55529-004-02 | Oxytetracycline Injection 200 | 100 mL vial | 9071-94E | Feb 2022 |
| 46066-007-02 | Terra-Vet 200 | 100 mL vial | 9071-94B | Feb 2022 |
| 30798-237-10 | Duramycin 72-200 | 100 mL vial | 9071-94A | Feb 2022 |
| 55529-006-02 | Flunixin Injection | 100 mL vial | 9092-91B | Feb 2022 |
| 13985-018-02 | Prevail Injection | 100 mL vial | 9092-91C | Feb 2022 |
| 46066-008-02 | Vetameg | 100 mL vial | 9092-91A | Feb 2022 |
| 55529-030-02 | Flunixin Injection –S | 100 mL vial | 9092-91D | Feb 2022 |
| 55529-131-11 | Carprieve Injection | 20 mL vial | 9035-90C | Jan 2021 |
| 11695-6934-1 | CarproJect Injection | 20 mL vial | 9035-90B | Jan 2021 |
| 11695-6934-1 | CarproJect Injection | 20 mL vial | 9084-91C | Feb 2021 |
| 14043-908-20 | Levafen Injection | 20 mL vial | 9035-90D | Jan 2021 |
| 14043-908-20 | Levafen Injection | 20 mL vial | 9084-91B | Feb 2021 |
| 14043-908-50 | Levafen Injection | 50 mL vial | 9035-91A | Jan 2021 |
| 13985-748-20 | OstiFen Injection | 20 mL vial | 9035-90A | Jan 2021 |
| 13985-748-20 | OstiFen Injection | 20 mL vial | 9084-91A | Feb 2021 |
| 55529-040-11 | Loxicom Injection | 20 mL vial | 9102-92A | Mar 2022 |
| 11695-6925-1 | EloxiJect Injection | 10 mL vial | 9102-91D | Mar 2022 |
| 11695-6925-2 | EloxiJect Injection | 20 mL vial | 9102-92B | Mar 2022 |
| 13985-559-10 | OstiLox Injection | 10 mL vial | 9102-91A | Mar 2022 |
| 13985-559-20 | OstiLox Injection | 20 mL vial | 9102-92C | Mar 2022 |
| 55529-154-02 | Enroflox Injection for Dogs 2.27% | 100 mL vial | 9034-92A | Jan 2021 |
| 55529-154-01 | Enroflox Injection for Dogs 2.27% | 50 mL vial | 9034-91B | Jan 2021 |
| 55529-154-11 | Enroflox Injection for Dogs 2.27% | 20 mL vial | 9034-90A | Jan 2021 |
| 55529-154-11 | Enroflox Injection for Dogs 2.27% | 20 mL vial | 9083-93A | Feb 2021 |
| 13985-709-20 | Enrosite Injection for Dogs 2.27% | 20 mL vial | 9034-90B | Jan 2021 |
| 13985-709-20 | Enrosite Injection for Dogs 2.27% | 20 mL vial | 9034-90C | Jan 2021 |
| 13985-709-20 | Enrosite Injection for Dogs 2.27% | 20 mL vial | 9083-93B | Feb 2021 |
| 13985-709-50 | Enrosite Injection for Dogs 2.27% | 50 mL vial | 9034-91A | Jan 2021 |
These injectable drug products were distributed nationwide in the USA 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 FDA’s 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).
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