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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Low RiskFDA Vet
Pets & Animals/Pet Medications

Sparhawk Laboratories Inc: Phenylbutazone 20% Injection Recalled Due to pH Stability Issues

Agency Publication Date: November 15, 2016
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Summary

Sparhawk Laboratories Inc. has recalled 14,553 cartons of Phenylbutazone 20% Injection (200 mg/mL), a veterinary pain medication for horses. The recall was initiated because the product's pH level was found to be out of specification during a 6-month stability test. This affects 100 mL glass vials sold under several brand names including Sparhawk, Vet One, Henry Schein, Phoenix, Aspen, and Vedco.

Risk

A medication with an incorrect pH level can lead to reduced drug stability and may cause irritation or localized tissue damage at the site of injection in animals. No injuries or adverse events have been reported to date.

What You Should Do

  1. Check your supply for Phenylbutazone 20% Injection (200 mg/mL) in 100 mL glass vials with lot number 150906 and an expiration date of 8/24/2017.
  2. Identify if your product is labeled under any of these brands: Sparhawk Laboratories Inc., Vet One (NDC 13985-825-04), Henry Schein Animal Health, Phoenix (NDC 57319-508-05), Aspen Veterinary Resources, Ltd., or Vedco, Inc. (NDC 60989-425-12).
  3. Immediately stop using the affected medication and quarantine any remaining stock to ensure it is not administered to animals.
  4. Contact your veterinarian, healthcare provider, or pharmacist for guidance regarding the use of this product and potential alternatives.
  5. Return any unused vials or cartons from lot 150906 to the place of purchase for a refund or contact Sparhawk Laboratories Inc. at 1-800-255-6380 for further return instructions.
  6. For additional questions or to report adverse events, contact the FDA Center for Veterinary Medicine at 1-888-FDA-VETS.

Your Remedy Options

💰Full Refund

Drug recall refund/return guidance

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

Affected Products

Product: Sparhawk Phenylbutazone 20% Injection (200 mg/mL - 100 mL)
Model:
ANADA 200-371
Lot Numbers:
150906 (Exp 8/24/2017)
Date Ranges: 8/24/2017
Product: Vet One Phenylbutazone 20% Injection (200 mg/mL - 100 mL)
Model:
NDC 13985-825-04
Lot Numbers:
150906 (Exp 8/24/2017)
Date Ranges: 8/24/2017
Product: Henry Schein Phenylbutazone 20% Injection (200 mg/mL - 100 mL)
Model:
ANADA 200-371
Lot Numbers:
150906 (Exp 8/24/2017)
Date Ranges: 8/24/2017
Product: Phoenix Phenylbutazone 20% Injection (200 mg/mL - 100 mL)
Model:
NDC 57319-508-05
Lot Numbers:
150906 (Exp 8/24/2017)
Date Ranges: 8/24/2017
Product: Aspen Veterinary Resources Phenylbutazone 20% Injection (200 mg/mL - 100 mL)
Model:
ANADA 200-371
Lot Numbers:
150906 (Exp 8/24/2017)
Date Ranges: 8/24/2017
Product: Vedco, Inc. Phenylbutazone 20% Injection (200 mg/mL - 100 mL)
Model:
NDC 60989-425-12
Lot Numbers:
150906 (Exp 8/24/2017)
Date Ranges: 8/24/2017

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 73769
Status: Resolved
Manufacturer: Sparhawk Laboratories Inc
Sold By: MWI; Henry Schein Animal Health; Clipper Distributing Company LLC; Aspen Veterinary Resources, Ltd.; Vedco, Inc.
Manufactured In: United States
Units Affected: 14,553 cartons
Distributed To: Kansas, Missouri, Ohio

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 · Raw API Response