Norbrook Inc: Hexasol Injection Recalled Due to Crystallization in Injectable Solution

Agency Publication Date: December 2, 2016

Summary

Approximately 8,907 vials of Hexasol Injection (oxytetracycline and flunixin meglumine), a veterinary medication, have been recalled because crystals were found floating in the liquid. These crystals can obstruct blood flow or cause tissue damage if the medication is administered to an animal. The recall includes 250 mL and 500 mL vials distributed across 10 states and Puerto Rico. Owners and veterinarians should stop using the affected vials immediately and contact a healthcare provider or the manufacturer for guidance.

Risk

The presence of crystals in an injectable solution poses a risk of embolism (blood vessel blockage) or severe inflammation at the injection site. If injected, these particulates could cause significant localized or systemic health issues for the animal being treated.

What You Should Do

Identify if you have the affected medication by checking the label for Hexasol Injection (oxytetracycline and flunixin meglumine).
Check for 250 mL vials with NDC 55529-016-04 and lot number 5281-94A, or 500 mL vials with NDC 55529-016-05 and lot number 5281-95A.
Verify if the expiration date on the package is July 2017.
Immediately stop using any vials matching these lot numbers and NDC codes.
Contact your veterinarian or healthcare provider to discuss alternative treatments and report any adverse effects in animals.
Return any unused product to the place of purchase for a refund and contact the manufacturer, Norbrook Inc, at their Lenexa, Kansas facility for further instructions.
For additional questions or to report animal safety issues, contact the FDA Center for Veterinary Medicine at 240-402-7002.

Your Remedy Options

Full Refund

Veterinary drug return and provider consultation.

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

Affected Products

Product: Hexasol Injection (oxytetracycline and flunixin meglumine) (250 mL)

Model:

NDC 55529-016-04

NADA 141-312

Lot Numbers:

5281-94A (Exp July 2017)

Date Ranges: Expiration date: July 2017

Product: Hexasol Injection (oxytetracycline and flunixin meglumine) (500 mL)

Model:

NDC 55529-016-05

NADA 141-312

Lot Numbers:

5281-95A (Exp July 2017)

Date Ranges: Expiration date: July 2017

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 75410

Status: Resolved

Manufacturer: Norbrook Inc

Sold By: veterinary distributors; animal health clinics

Manufactured In: United Kingdom, United States

Units Affected: 8907 vials

Distributed To: Florida, Iowa, Kansas, Kentucky, Louisiana, Missouri, Minnesota, North Dakota, Nebraska, Oklahoma, Puerto Rico

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.

Find an Attorney

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 · Raw API Response

Summary

What You Should Do

Identify if you have the affected medication by checking the label for Hexasol Injection (oxytetracycline and flunixin meglumine).

Check for 250 mL vials with NDC 55529-016-04 and lot number 5281-94A, or 500 mL vials with NDC 55529-016-05 and lot number 5281-95A.

Verify if the expiration date on the package is July 2017.

Immediately stop using any vials matching these lot numbers and NDC codes.

Contact your veterinarian or healthcare provider to discuss alternative treatments and report any adverse effects in animals.

Return any unused product to the place of purchase for a refund and contact the manufacturer, Norbrook Inc, at their Lenexa, Kansas facility for further instructions.

For additional questions or to report animal safety issues, contact the FDA Center for Veterinary Medicine at 240-402-7002.

Affected Products

Product: Hexasol Injection (oxytetracycline and flunixin meglumine) (250 mL)

Model:

NDC 55529-016-04

NADA 141-312

Lot Numbers:

5281-94A (Exp July 2017)

Date Ranges: Expiration date: July 2017

Product: Hexasol Injection (oxytetracycline and flunixin meglumine) (500 mL)

Model:

NDC 55529-016-05

NADA 141-312

Lot Numbers:

5281-95A (Exp July 2017)

Date Ranges: Expiration date: July 2017

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 75410

Status: Resolved

Manufacturer: Norbrook Inc

Sold By: veterinary distributors; animal health clinics

Manufactured In: United Kingdom, United States

Units Affected: 8907 vials

Distributed To: Florida, Iowa, Kansas, Kentucky, Louisiana, Missouri, Minnesota, North Dakota, Nebraska, Oklahoma, Puerto Rico