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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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Medium RiskFDA Drug
Medications & Supplements/Prescription Drugs

PAI Holdings, LLC. dba Pharmaceutical Associates Inc: Nystatin Oral Suspension Recalled Due to Subpotency

Agency Publication Date: August 12, 2020
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Summary

Approximately 7,416 bottles of Nystatin Oral Suspension (100,000 units per mL) in Cherry/Peppermint flavor are being recalled because the medication was found to be subpotent during a routine 15-month test. This means the drug may not have the full strength required to effectively treat fungal infections as intended. If you are using this medication, contact your healthcare provider or pharmacist to discuss your treatment and obtain a replacement.

Risk

The medication is subpotent, meaning it contains less of the active ingredient than the label states. This can lead to ineffective treatment of fungal infections, potentially allowing the infection to persist or worsen.

What You Should Do

  1. Check your medication bottle for Nystatin Oral Suspension, USP 100,000 units per mL in a 16 fl. oz. (473 mL) size with NDC 0121-0810-16.
  2. Identify if your bottle is from Lot B973 with an expiration date of 11/20 (November 2020).
  3. If your product matches the affected lot, contact your healthcare provider or pharmacist immediately for guidance on your treatment.
  4. Return any unused portion of the recalled medication to the pharmacy where it was purchased for a refund.
  5. Contact PAI Holdings (Pharmaceutical Associates Inc) at their Greenville, SC location or visit their website for further instructions regarding this recall.
  6. For additional questions, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

๐Ÿ’ฐFull Refund

Refund or replacement through pharmacy

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

Affected Products

Product: Nystatin Oral Suspension, USP 100,000 units per mL, Cherry/Peppermint Flavor (16 fl. oz. / 473 mL)
Model:
NDC 0121-0810-16
Recall #: D-1494-2020
Lot Numbers:
B973 (Exp 11/20)
Date Ranges: Expires 11/20

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 86170
Status: Resolved
Manufacturer: PAI Holdings, LLC. dba Pharmaceutical Associates Inc
Sold By: Pharmacies
Manufactured In: United States
Units Affected: 7416 bottles
Distributed To: Nationwide
Agency Last Updated: August 27, 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 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.