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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 Drug
Medications & Supplements/Prescription Drugs

VistaPharm Mycophenolate Mofetil Oral Suspension Recalled for Defective Adaptor

Agency Publication Date: November 8, 2023
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Summary

VistaPharm LLC is recalling 11,633 bottles of Mycophenolate Mofetil for Oral Suspension (200 mg/mL) because the container adaptor does not fit into the neck of the bottle after it is mixed with water. This defect can prevent the proper administration of the medication. No injuries or incidents have been reported to date, but consumers are advised to contact their healthcare provider if they have concerns.

Risk

The defective adaptor prevents the proper seal or connection required to dose the medication. This could lead to dosing errors or difficulty using the prescribed treatment effectively.

What You Should Do

  1. The recalled product is Mycophenolate Mofetil for Oral Suspension, USP, 200 mg/mL, an Rx-only medication in a bottle (NDC 66689-307-08).
  2. Check your bottle for the following lot numbers and expiration dates: M23400A, M23401A, and M23402A (expiration April 30, 2025); and M23591A and M23592A (expiration June 30, 2025).
  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 VistaPharm LLC for further instructions.
  4. Call the FDA Consumer Complaint hotline at 1-888-723-3332 or visit www.fda.gov/safety/recalls for more information.

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: Mycophenolate Mofetil for Oral Suspension, USP
Variants: 200 mg/mL, Oral Suspension
Lot Numbers:
M23400A (Exp 04/30/2025)
M23401A (Exp 04/30/2025)
M23402A (Exp 04/30/2025)
M23591A (Exp 06/30/2025)
M23592A (Exp 06/30/2025)
NDC:
66689-307-08

Quantity affected: 11,633 bottles

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 93322
Status: Resolved
Manufacturer: VistaPharm LLC
Sold By: pharmacies; healthcare providers
Manufactured In: United States
Units Affected: 11,633 bottles
Distributed To: Nationwide

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.