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Critical RiskFDA Vet
Pets & Animals/Pet Medications

NORBROOK INC: Various Animal Injectable Medications Recalled Due to Sterility Concerns

Agency Publication Date: June 14, 2019
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Summary

Norbrook Inc. has recalled approximately 58,052 vials of various sterile injectable medications for livestock and pets, including popular brands like Enroflox 100, Noromycin 300 LA, and Carprieve. The recall was initiated because the products failed a 'media fill' test, which means the manufacturing process cannot guarantee the medications are completely sterile. These products were distributed to veterinary clinics and animal health suppliers in 11 states between May 2019 and early 2022.

Risk

If an injectable medication is not sterile, it may contain bacteria or other contaminants that can cause serious infections or abscesses at the injection site, or life-threatening systemic illness in treated animals.

What You Should Do

  1. Check your animal medications for the following specific brands: Enroflox 100, 300 PRO LA, Noromycin 300 LA, Carprieve, Carproject, Levafen, OstiFen, Enroflox Injection 2.27%, Enrosite, Duramycin 72-200, Oxytetracycline 200, Terra-Vet 200, Flunixin, Prevail, Vetameg, Flunixin-S, EloxiJect, Loxicom, OstiLox, and Noromectin Plus.
  2. For Enroflox 100 (100 mL), verify if your vial belongs to Lot 9075-90A with an expiration of Feb 2022.
  3. For Oxytetracycline 300 mg/mL brands, check for Lot 9063-90B (300 PRO LA) or Lot 9063-90A (Noromycin 300 LA), both expiring Feb 2022.
  4. For Carprofen (50 mg/mL) brands, look for lot numbers 9035-90C, 9035-90B, 9084-91C, 9035-90D, 9084-91B, 9035-91A, 9035-90A, or 9084-91A with expiration dates in Jan/Feb 2021.
  5. For Meloxicam brands (EloxiJect, Loxicom, OstiLox), check for lots 9102-91D, 9102-92B, 9102-92A, 9102-91A, or 9102-92C with an expiration of Mar 2022.
  6. Contact your veterinarian or animal healthcare provider immediately if your animal was treated with these specific lots and shows signs of infection or unusual swelling at the injection site.
  7. Return any unused vials to your place of purchase for a refund and contact Norbrook Inc. at their Overland Park, KS location for further instructions.
  8. Call the FDA's Center for Veterinary Medicine at 1-240-402-7002 for additional questions regarding this safety alert.

Your Remedy Options

๐Ÿ’ฐFull Refund

Contact healthcare provider and return product for refund.

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: Enroflox 100 (Enrofloxacin) Sterile Injectable Solution, 100 mg/mL (100 mL vial)
Model:
NDC: 55529-152-02
Lot Numbers:
9075-90A (Exp Feb 2022)
Date Ranges: Expiry Date Feb 2022
Product: 300 PRO LA (Oxytetracycline) Sterile Injectable Solution, 300 mg/mL (100 mL vial)
Model:
NDC 55529-014-02
Lot Numbers:
9063-90B (Exp Feb 2022)
Date Ranges: Expiry Date Feb 2022
Product: Noromycin 300 LA (Oxytetracycline) Sterile Injectable Solution, 300 mg/mL (100 mL vial)
Model:
NDC 55529-015-02
Lot Numbers:
9063-90A (Exp Feb 2022)
Date Ranges: Expiry Date Feb 2022
Product: Carprieve Injection (Carprofen) 50 mg/mL (20 mL vial)
Model:
NDC 55529-131-11
Lot Numbers:
9035-90C (Exp Jan 2021)
Date Ranges: Expiry Date Jan 2021
Product: Carproject Injection (Carprofen) 50 mg/mL (20 mL vial)
Model:
NDC 11695-6934-1
Lot Numbers:
9035-90B (Exp 1/1/2021)
9084-91C (Exp Jan 2021)
Date Ranges: Expiry Date Jan 2021
Product: Levafen Injection (Carprofen) 50 mg/mL (20 mL and 50 mL vials)
Model:
NDC 14043-908-20
NDC 14043-908-50
Lot Numbers:
9035-90D (Exp Jan 2021)
9084-91B (Exp Feb 2021)
9035-91A (Exp Jan 2021)
Date Ranges: Expiry Date Jan 2021, Expiry Date Feb 2021
Product: OstiFen Injection (Carprofen) 50 mg/mL (20 mL vial)
Model:
NDC 13985-748-20
Lot Numbers:
9035-90A (Exp 1/1/2021)
9084-91A (Exp Feb 2021)
Date Ranges: Expiry Date Jan 2021, Expiry Date Feb 2021
Product: Enroflox Injection for Dogs 2.27% (Enrofloxacin) (20 mL, 50 mL, or 100 mL vials)
Model:
NDC 55529-154-11
NDC 55529-154-01
NDC 55529-154-02
Lot Numbers:
9034-90A (Exp Jan 2021)
9083-93A (Exp Feb 2021)
9034-91B (Exp Jan 2021)
9034-92A (Exp Jan 2021)
Date Ranges: Expiry Date Jan 2021, Expiry Date Feb 2021
Product: Enrosite Injection for Dogs 2.27% (Enrofloxacin) (20 mL and 50 mL vials)
Model:
NDC 13985-709-20
NDC 13985-709-50
Lot Numbers:
9034-90B (Exp Jan 2021)
9034-90C (Exp Jan 2021)
9083-93B (Exp Feb 2021)
9034-91A (Exp Jan 2021)
Date Ranges: Expiry Date Jan 2021, Expiry Date Feb 2021
Product: Duramycin 72-200 (Oxytetracycline) 200 mg/mL (100 mL vial)
Model:
NDC 30798-237-10
Lot Numbers:
9071-94A (Exp Feb 2022)
Date Ranges: Expiry Date Feb 2022
Product: Oxytetracycline Injection 200 (200 mg/mL) (100 mL vial)
Model:
NDC 55529-004-02
Lot Numbers:
9071-94D (Exp Feb 2022)
9071-94E (Exp Feb 2022)
9071-94C (Exp Feb 2022)
Date Ranges: Expiry Date Feb 2022
Product: Terra-Vet 200 (Oxytetracycline) 200 mg/mL (100 mL vial)
Model:
NDC 46066-007-02
Lot Numbers:
9071-94B (Exp Feb 2022)
Date Ranges: Expiry Date Feb 2022
Product: Flunixin Injection (Flunixin meglumine) 50 mg/mL (100 mL vial)
Model:
NDC 55529-006-02
Lot Numbers:
9092-91B (Exp Feb 2022)
Date Ranges: Expiry Date Feb 2022
Product: Prevail Injection (Flunixin meglumine) 50 mg/mL (100 mL vial)
Model:
NDC 13985-018-02
Lot Numbers:
9092-91C (Exp Feb 2022)
Date Ranges: Expiry Date Feb 2022
Product: Vetameg (Flunixin meglumine) 50 mg/mL (100 mL vial)
Model:
NDC 46066-008-02
Lot Numbers:
9092-91A (Exp Feb 2022)
Date Ranges: Expiry Date Feb 2022
Product: Flunixin Injection-S (Flunixin meglumine) 50 mg/mL (100 mL vial)
Model:
NDC 55529-030-02
Lot Numbers:
9092-91D (Exp Feb 2022)
Date Ranges: Expiry Date Feb 2022
Product: EloxiJect Injection (Meloxicam) 5 mg/mL (10 mL or 20 mL vial)
Model:
NDC 11695-6925-1
NDC 11695-6925-2
Lot Numbers:
9102-91D
9102-92B (Exp Mar 2022)
Date Ranges: Expiry Date Mar 2022
Product: Loxicom Injection (Meloxicam) 5 mg/mL (10 mL or 20 mL vial)
Model:
NDC 55529-040-11
Lot Numbers:
9102-92A (Exp Mar 2022)
Date Ranges: Expiry Date Mar 2022
Product: OstiLox Injection (Meloxicam) 5 mg/mL (10 mL or 20 mL vial)
Model:
NDC 13985-559-10
NDC 13985-559-20
Lot Numbers:
9102-91A
9102-92C (Exp Mar 2022)
Date Ranges: Expiry Date Mar 2022
Product: Noromectin Plus Injection for Cattle (Ivermectin/Clorsulon) 50 mL vial
Model:
NDC 55529-011-01
Lot Numbers:
9065-90A (Exp Feb 2022)
Date Ranges: Expiry Date Feb 2022

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 82869
Status: Resolved
Manufacturer: NORBROOK INC
Sold By: veterinary clinics; animal health distributors
Manufactured In: United Kingdom, United States
Units Affected: 9 products (17,064 vials; 900 vials 300 PRO LA; 18,504 vials Noromycin 300 LA; CARPRIEVE 2,492 vials; CARPROJECT 11,838 vials; LEVAFEN: 5,610 vials; OSTIFEN 6,984 vials; Enroflox: 16,236 vials; Enrosite: 10,224 vials; Duramycin 72-200: 10,368 vials; Oxytetracycline Injection 200: 1,681 vials; Flunixin: 4,848 vials; Prevail: 6,912 vials; Vetameg: 3,456 vials; 6,912 vials; ELOXIJECT: 7,056 vials; LOXICOM: 144 vials; 11,592 vials; 2,472 vials)
Distributed To: Missouri, Iowa, Kentucky, California, Virginia, Ohio, New York, Arkansas, Idaho, Kansas, Texas
Agency Last Updated: January 21, 2020

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

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This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response