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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 Oral Suspension Recalled Due to Superpotency

Agency Publication Date: April 17, 2018
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Summary

Lupin Pharmaceuticals Inc. has recalled 40,824 bottles of Cefdinir powder for Oral Suspension USP, 250 mg/5 mL, which is a prescription antibiotic (generic Omnicef). The recall was initiated because the drug was found to be superpotent, meaning it contains more of the active ingredient than specified. Taking a higher dose than intended could lead to unintended side effects or toxicity, especially in pediatric patients. The affected products were distributed nationwide in 60 mL and 100 mL bottles and should be returned to the pharmacy.

Risk

The product is superpotent, containing levels of Cefdinir that exceed the labeled dosage. This could result in patients receiving a higher-than-prescribed dose, potentially increasing the risk of adverse reactions or complications associated with the medication.

What You Should Do

  1. Check your prescription bottle for Lupin Cefdinir powder for Oral Suspension USP, 250 mg/5 mL in either 60 mL (NDC 68180-723-20) or 100 mL (NDC 68180-723-10) pack sizes.
  2. Verify the lot number and expiration date on the label to see if they match the following: Lot # F602241 (Exp. 10/18), Lot # F602577 (Exp. 11/18), or Lot # F700036 (Exp. 12/18).
  3. Contact your healthcare provider or pharmacist immediately for guidance if you or your child are currently taking medication from an affected lot.
  4. Return any remaining unused product to your pharmacy for a refund and to obtain a safe replacement prescription.
  5. Contact Lupin Pharmaceuticals Inc. at their Baltimore, Maryland headquarters for further instructions regarding this recall.
  6. 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

๐Ÿ’ฐFull Refund

Drug recall baseline remedy

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

Affected Products

Product: Lupin Cefdinir powder for Oral Suspension USP, 250 mg/5 mL (60 mL pack)
Model:
NDC 68180-723-20
D-0684-2018
Lot Numbers:
F602241 (Exp. 10/18)
F602577 (Exp. 11/18)
F700036 (Exp. 12/18)
Date Ranges: Expiration 10/18, Expiration 11/18, Expiration 12/18
Product: Lupin Cefdinir powder for Oral Suspension USP, 250 mg/5 mL (100 mL pack)
Model:
NDC 68180-723-10
D-0684-2018
Lot Numbers:
F602241 (Exp. 10/18)
F602577 (Exp. 11/18)
F700036 (Exp. 12/18)
Date Ranges: Expiration 10/18, Expiration 11/18, Expiration 12/18

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 79612
Status: Resolved
Manufacturer: Lupin Pharmaceuticals Inc.
Sold By: Pharmacies
Manufactured In: United States
Units Affected: 40,824 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.