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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

Lupin Pharmaceuticals Inc.: Cefdinir for Oral Suspension Recalled for High Potency (Superpotent)

Agency Publication Date: July 23, 2020
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Summary

Lupin Pharmaceuticals Inc. is voluntarily recalling approximately 35,928 bottles of Cefdinir for Oral Suspension USP (250 mg/5mL), an antibiotic used to treat bacterial infections. This recall was initiated after testing of retention samples showed the medication was 'superpotent,' meaning it contains more of the active ingredient than the specification allows. Consumers should contact their healthcare provider or pharmacist regarding this recall and for guidance on their medication. These prescription bottles were distributed nationwide across the United States.

Risk

The drug tested as out-of-specification for potency, which could result in patients receiving a higher dose of the antibiotic than intended. While the specific health consequences were not detailed in the report, superpotent medications can increase the risk of side effects or adverse reactions associated with the drug.

What You Should Do

  1. Identify your medication by checking the label for 'Cefdinir for Oral Suspension USP, 250 mg/5mL' in 60 mL bottles with NDC 68180-723-20.
  2. Check the bottle for the following affected lot numbers and expiration dates: Lot F802189 (Exp 10/2020) and Lot F900240 (Exp 1/2021).
  3. Contact your healthcare provider or pharmacist immediately to discuss your treatment and determine if you have an affected bottle.
  4. Return any unused portions of the affected medication to your pharmacy for a refund and to ensure proper disposal.
  5. Contact Lupin Pharmaceuticals Inc. at their Baltimore office or through your dispensing pharmacy for further instructions regarding the return process.
  6. For additional questions or to report a problem, 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

Healthcare provider consultation and pharmacy return.

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

Affected Products

Product: Cefdinir for Oral Suspension USP, 250 mg/5mL (60 mL bottle)
Model:
NDC 68180-723-20
D-1406-2020
Lot Numbers:
F802189 (Exp 10/2020)
F900240 (Exp 1/2021)
Date Ranges: Expiration 10/2020, Expiration 1/2021

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 85960
Status: Resolved
Manufacturer: Lupin Pharmaceuticals Inc.
Sold By: Pharmacies
Manufactured In: India, United States
Units Affected: 35,928 bottles
Distributed To: Nationwide

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.