US Compounding Inc: Aluminum Hydroxide Oil Oral Suspension Recalled for Stability Failure

Agency Publication Date: March 30, 2020

Summary

US Compounding Inc. is recalling approximately 1,330 mL of Aluminum Hydroxide Oil 120 mg/mL Oral Suspension, a veterinary medication, due to a failure in stability testing. This failure means the product may not remain effective or safe through its originally labeled shelf life, requiring an adjustment to the expiration date. Consumers who have purchased this medication should check their lot numbers and contact their veterinarian or pharmacist immediately.

Risk

The product failed stability testing, which can lead to a loss of potency or chemical changes in the medication. This could result in ineffective treatment for the animal's condition or unexpected side effects.

What You Should Do

Check your product label for 'Aluminum Hydroxide Oil 120 mg/mL Oral Suspension' with NDC 22200025824 and the US Compounding Pharmacy name.
Locate the lot number and Beyond Use Date (BUD) on the bottle to see if it matches any of the following: 12302019@5 (BUD 07/26/2020), 01282020@3 (BUD 07/26/2020), 01292020@7 (BUD 07/27/2020), 03042020@11 (BUD 08/31/2020), or 03052020@14 (BUD 09/01/2020).
Contact your veterinarian or pharmacist immediately for guidance on whether to continue use or if a replacement is required due to the adjusted expiration dates.
Return any unused product to the pharmacy or place of purchase for a refund.
If you have further questions, contact US Compounding Inc. at 800-718-3588.
For additional questions, you can contact the FDA Center for Veterinary Medicine at 240-402-7002.

Your Remedy Options

Full Refund

Drug recall remedy

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

Affected Products

Product: Aluminum Hydroxide Oil 120 mg/mL Oral Suspension (1330 mL total affected)

Model:

NDC 22200025824

Lot Numbers:

12302019@5 (Exp 07/26/2020)

01282020@3 (Exp 07/26/2020)

01292020@7 (Exp 07/27/2020)

03042020@11 (Exp 08/31/2020)

03052020@14 (Exp 09/01/2020)

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 85316

Status: Resolved

Manufacturer: US Compounding Inc

Sold By: US Compounding Pharmacy

Manufactured In: United States

Units Affected: 1330 mL

Distributed To: Washington, Maryland

Agency Last Updated: September 8, 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.

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

Check your product label for 'Aluminum Hydroxide Oil 120 mg/mL Oral Suspension' with NDC 22200025824 and the US Compounding Pharmacy name.

Locate the lot number and Beyond Use Date (BUD) on the bottle to see if it matches any of the following: 12302019@5 (BUD 07/26/2020), 01282020@3 (BUD 07/26/2020), 01292020@7 (BUD 07/27/2020), 03042020@11 (BUD 08/31/2020), or 03052020@14 (BUD 09/01/2020).

Contact your veterinarian or pharmacist immediately for guidance on whether to continue use or if a replacement is required due to the adjusted expiration dates.

Return any unused product to the pharmacy or place of purchase for a refund.

If you have further questions, contact US Compounding Inc. at 800-718-3588.

For additional questions, you can contact the FDA Center for Veterinary Medicine at 240-402-7002.