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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, Cimetidine, and Ethosuximide Recalled for Potential Contamination

Agency Publication Date: August 10, 2021
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Summary

PAI Holdings, LLC (Pharmaceutical Associates Inc) is recalling approximately 1,477 cases of three different liquid prescription medications: Nystatin Oral Suspension, Cimetidine Hydrochloride Oral Solution, and Ethosuximide Oral Solution. The recall was initiated because the products may have been contaminated with Senna Syrup during the manufacturing process due to a lack of current Good Manufacturing Practices (CGMP). These medications are used to treat fungal infections, stomach acid issues, and seizures, respectively.

Risk

The medications may contain carry-over traces of Senna Syrup, a laxative, which was not intended to be in these formulations. This cross-contamination can lead to unexpected side effects or reduced effectiveness of the prescribed treatment.

What You Should Do

  1. Check your medication bottles for the following specific identifiers: Nystatin Oral Suspension (16 fl oz NDC 0121-0868-16 or 2 fl oz NDC 0121-0868-02), Cimetidine Hydrochloride (8 fl oz NDC 0121-0649-08), or Ethosuximide Oral Solution (16 fl oz NDC 0121-0670-16).
  2. If you have Nystatin, verify if your bottle belongs to lots C98F, C990 (Exp. 30SEP2022), C9C2 (Exp. 31OCT2022), or C9E1 (Exp. 31OCT2022).
  3. If you have Cimetidine, check for lot C62F (Exp. 31OCT2022); if you have Ethosuximide, check for lot C9BC (Exp. 31OCT2022).
  4. Immediately contact your healthcare provider or pharmacist for guidance if you find you have an affected bottle.
  5. Return any unused product to the pharmacy where it was purchased for a refund and contact Pharmaceutical Associates Inc for further instructions regarding the return process.
  6. Contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls for additional questions.

Your Remedy Options

๐Ÿ’ฐFull Refund

Contact healthcare provider and return to 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 (16 fl oz / 473 mL)
Model:
NDC 0121-0868-16
Lot Numbers:
C98F
C990 (Exp. 30SEP2022)
C9C2 (Exp. 31OCT2022)
Date Ranges: Expiration 30SEP2022, Expiration 31OCT2022
Product: Nystatin Oral Suspension, USP 100,000 units per mL (2 fl oz / 60 mL)
Model:
NDC 0121-0868-02
Lot Numbers:
C9E1 (Exp. 31OCT2022)
Date Ranges: Expiration 31OCT2022
Product: Cimetidine Hydrochloride Oral Solution 300 mg/5 mL (8 fl oz / 237 mL)
Model:
NDC 0121-0649-08
Lot Numbers:
C62F (Exp. 31OCT2022)
Date Ranges: Expiration 31OCT2022
Product: Ethosuximide Oral Solution USP 250 mg/5 mL (16 fl oz / 473 mL)
Model:
NDC 0121-0670-16
Lot Numbers:
C9BC (Exp. 31OCT2022)
Date Ranges: Expiration 31OCT2022

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 88392
Status: Resolved
Manufacturer: PAI Holdings, LLC. dba Pharmaceutical Associates Inc
Sold By: Pharmacies
Manufactured In: United States
Units Affected: 3 products (a) 1002 cases (12 bottles/case); b) 458 cases (24 bottles/case); 400 cases (12 bottles/case); 75 cases (6 bottles/case))
Distributed To: Nationwide
Agency Last Updated: August 12, 2021

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.