Medications & Supplements/Prescription Drugs

Precision Dose Inc.: Ranitidine Oral Solution Recalled Due to NDMA Impurity

Agency Publication Date: March 12, 2020

Summary

Precision Dose Inc. is recalling approximately 224,940 unit dose cups of Ranitidine Oral Solution, USP, 150 mg/10 mL. This prescription medication, commonly used to treat acid reflux and ulcers, was found to contain an impurity called N-nitrosodimethylamine (NDMA). The recall affects multiple batches distributed nationwide in the United States and specifically involves the 10 mL unit dose cups used in clinical and hospital settings.

Risk

NDMA is classified as a probable human carcinogen based on results from laboratory tests. While it is a known environmental contaminant found in water and foods, the presence of this impurity in the drug's active ingredient exceeds acceptable safety levels, potentially increasing the risk of cancer over long-term exposure.

What You Should Do

Check your medication packaging for Ranitidine Oral Solution, USP, 150 mg/10 mL with the following identifying codes: Lot 501290 (Exp 11/30/19, NDC 68094-204-61), Lot 501326 (Exp 11/30/19, NDC 68094-204-62), Lot 501501 (Exp 11/30/19, NDC 68094-204-62), Lot 1592 (Exp 4/30/20, NDC 68094-204-62), or Lot 501679 (Exp 4/30/20, NDC 68094-204-61 or 68094-204-62).
Contact your healthcare provider or pharmacist immediately for guidance on alternative treatments and to determine if your specific supply is part of the recall.
Return any unused or remaining product to the pharmacy or place of purchase for a refund.
Contact Precision Dose Inc. at their South Beloit, Illinois location for further instructions regarding the return process.
For additional questions or to report a complaint, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

Full Refund

Healthcare provider consultation and pharmacy refund.

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

Affected Products

Product: Ranitidine Oral Solution, USP, 150 mg/10 mL (10 mL unit dose cups)

Model:

NDC: 68094-204-62

NDC: 68094-204-61

NDC: 68094-204-59

Lot Numbers:

501290 (Exp 11/30/19)

501326 (Exp 11/30/19)

501501 (Exp 11/30/19)

1592 (Exp 4/30/20)

501679 (Exp 4/30/20)

Date Ranges: 11/30/19, 4/30/20

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 85039

Status: Resolved

Manufacturer: Precision Dose Inc.

Sold By: hospitals; clinics; pharmacies

Manufactured In: United States

Units Affected: 224,940 unit dose cups

Distributed To: Nationwide

Agency Last Updated: April 15, 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 · 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.

Summary

Risk

What You Should Do

Check your medication packaging for Ranitidine Oral Solution, USP, 150 mg/10 mL with the following identifying codes: Lot 501290 (Exp 11/30/19, NDC 68094-204-61), Lot 501326 (Exp 11/30/19, NDC 68094-204-62), Lot 501501 (Exp 11/30/19, NDC 68094-204-62), Lot 1592 (Exp 4/30/20, NDC 68094-204-62), or Lot 501679 (Exp 4/30/20, NDC 68094-204-61 or 68094-204-62).

Contact your healthcare provider or pharmacist immediately for guidance on alternative treatments and to determine if your specific supply is part of the recall.

Return any unused or remaining product to the pharmacy or place of purchase for a refund.

Contact Precision Dose Inc. at their South Beloit, Illinois location for further instructions regarding the return process.

For additional questions or to report a complaint, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.