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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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Critical RiskFDA Drug
Medications & Supplements/Prescription Drugs

Valor Compounding Pharmacy Tacrolimus Suspension Recalled for Subpotency

Agency Publication Date: June 9, 2022
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Summary

Valor Compounding Pharmacy is recalling 2,916 mLs of compounded Tacrolimus 0.5 mg/mL Suspension because the medication was found to be subpotent. This means the liquid suspension contains less than the intended amount of active medication, which may prevent it from working as prescribed. The product was distributed in California in bottle sizes ranging from 2 oz to 16 oz. No injuries or medical incidents have been reported to date.

Risk

If a patient takes subpotent Tacrolimus, they receive an insufficient dose of the medication required to manage their condition. Because Tacrolimus is used to prevent organ rejection after a transplant, receiving too little medication could lead to serious health complications or transplant failure.

What You Should Do

  1. This recall affects compounded Tacrolimus 0.5 mg/mL Suspension distributed by Valor Compounding Pharmacy in bottle sizes of 2 oz, 6 oz, 8 oz, 12 oz, and 16 oz.
  2. Check your medication bottle for lot number 03312022@29 (Best Use Date 6/10/2022) or lot number 04272022@35 (Best Use Date 7/7/2022).
  3. If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact the manufacturer for further instructions.
  4. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions regarding this recall.

Your Remedy Options

You have 2 options:

๐Ÿ’ฐOption 1: Full Refund
How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund
๐Ÿ—‘๏ธOption 2: Dispose of Product
How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Tacrolimus 0.5 mg/mL Suspension (Recall #: D-1167-2022)
Variants: 0.5 mg/mL, 12 oz bottle, 2 oz bottle, 16 oz bottle, 6 oz bottle
Lot Numbers:
03312022@29 (BUD 6/10/2022)

Quantity: 1,966 mLs. This is a compounded medication.

Product: Tacrolimus 0.5 mg/mL Suspension (Recall #: D-1168-2022)
Variants: 0.5 mg/mL, 8 oz bottle, 16 oz bottle
Lot Numbers:
04272022@35 (BUD 7/7/2022)

Quantity: 950 mLs. This is a compounded medication.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 90289
Status: Resolved
Manufacturer: Valor Compounding Pharmacy, Inc DBA Valor Compounding Pharmacy
Sold By: Valor Compounding Pharmacy
Manufactured In: United States
Units Affected: 2 products (1,966 mLs in 12 oz; 2 oz; 16 oz and 6 oz bottles; 950 mLs in 1x8 oz and 2x16 oz bottles.)
Distributed To: California
Agency Last Updated: June 28, 2022

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 ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.