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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

Shionogi Inc.: Mefenamic Acid Capsules Recalled Due to Foreign Black Particles

Agency Publication Date: January 12, 2018
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Summary

Shionogi Inc. is recalling 968 bottles of Mefenamic Acid Capsules (generic Ponstel), 250 mg, which were sold in 30-count bottles. This recall was initiated after black particles were discovered in the medication during routine stability testing. Consumers should check their prescription bottles immediately to see if they have the affected lot.

Risk

The presence of unidentified black particles in the medication means the product is contaminated with a foreign substance. Ingesting these particles could pose a health risk or lead to unexpected side effects, as the purity of the drug cannot be guaranteed.

What You Should Do

  1. Identify your medication: Check if you have Mefenamic Acid Capsules, USP, 250 mg, in a 30-count bottle distributed by Prasco Laboratories.
  2. Check the lot number and expiration: Look for lot number 7H66200103G with an expiration date of 12/19 printed on the bottle label.
  3. Verify the NDC: Confirm the National Drug Code (NDC) on the bottle is 66993-070-30.
  4. Contact your healthcare provider: If you have the affected product, contact your doctor or pharmacist for guidance. Do not stop taking a prescribed medication without consulting a professional.
  5. Return for refund: Return any unused product from the recalled lot to the pharmacy where it was purchased for a refund and contact Shionogi Inc. for further instructions.
  6. Contact the FDA: For additional questions or to report a problem, call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA).

Your Remedy Options

๐Ÿ’ฐFull Refund

Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund and contact the manufacturer for instructions.

Affected Products

Product: Mefenamic Acid Capsules, USP, 250 mg (30-count bottle)
Model:
NDC 66993-070-30
D-0219-2018
Lot Numbers:
7H66200103G (Exp 12/19)
Date Ranges: Expiration 12/19

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 78851
Status: Resolved
Manufacturer: Shionogi Inc.
Sold By: Prasco Laboratories; Pharmacies
Manufactured In: United States
Units Affected: 968 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.