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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.: Cefprozil for Oral Suspension Recalled for Superpotency

Agency Publication Date: April 12, 2021
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Summary

Lupin Pharmaceuticals Inc. has recalled approximately 17,814 bottles of Cefprozil for Oral Suspension USP (250mg/5mL) because the medication is superpotent, meaning it contains more of the active drug than it should. The recall affects 50 mL, 75 mL, and 100 mL bottles manufactured in India and distributed nationwide across the United States and Puerto Rico. This antibiotic medication was sold by prescription and intended for oral use in patients. Consumers should check their prescription bottles immediately to see if their medication is part of the affected lots.

Risk

A superpotent drug contains a higher concentration of active ingredients than prescribed, which can lead to unintended side effects or toxicity. Because this is an antibiotic, receiving a higher dose than intended may increase the risk of adverse reactions and complications for patients, particularly those with sensitive health conditions.

What You Should Do

  1. Locate your Cefprozil for Oral Suspension USP (250mg/5mL) bottle and check the label for the following identifying details: NDC 68180-402-01 (50 mL), NDC 68180-402-02 (75 mL), or NDC 68180-402-03 (100 mL).
  2. Check the bottle for Lot Number F801122 (50 mL), F801123 (75 mL), or F801124 (100 mL), all with an expiration date of June 2021.
  3. If you have an affected bottle, contact your healthcare provider or pharmacist immediately for guidance on how to safely proceed with your treatment.
  4. Return any unused portion of the medication to the pharmacy where you purchased it for a refund.
  5. Contact Lupin Pharmaceuticals Inc. at their Baltimore, Maryland office for further instructions regarding this recall.
  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 guidance and product refund

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

Affected Products

Product: Cefprozil for Oral Suspension USP, 250mg/5mL (50 mL bottles)
Model:
NDC 68180-402-01
Recall #: D-0332-2021
Lot Numbers:
F801122 (Exp June 2021)
Date Ranges: June 2021
Product: Cefprozil for Oral Suspension USP, 250mg/5mL (75 mL bottles)
Model:
NDC 68180-402-02
Recall #: D-0332-2021
Lot Numbers:
F801123 (Exp June 2021)
Date Ranges: June 2021
Product: Cefprozil for Oral Suspension USP, 250mg/5mL (100 mL bottles)
Model:
NDC 68180-402-03
Recall #: D-0332-2021
Lot Numbers:
F801124 (Exp June 2021)
Date Ranges: June 2021

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 87602
Status: Resolved
Manufacturer: Lupin Pharmaceuticals Inc.
Sold By: Pharmacies
Manufactured In: India, United States
Units Affected: a) 6,816 bottles; b) 3,960 bottles and c) 7,038 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.