Medications & Supplements/Prescription Drugs

Lupin Pharmaceuticals Inc.: Cefdinir for Oral Suspension Recalled for Potential Metal Contamination

Agency Publication Date: May 30, 2019

Summary

Lupin Pharmaceuticals Inc. has recalled approximately 18,408 bottles of Cefdinir for Oral Suspension USP, 250mg/5mL, after a consumer reported finding a metal piece in the product bottle before the powder was mixed with water. Cefdinir is a prescription antibiotic used to treat various bacterial infections. This recall specifically affects 60 mL bottles from lot F802335 with an expiration date of November 2020. If you have this medication, you should consult your healthcare provider or pharmacist immediately to ensure your treatment is not interrupted.

Risk

The presence of a foreign metal object in the medication bottle poses a risk of choking, oral injury, or internal damage if the metal piece is accidentally ingested during administration of the reconstituted liquid medicine.

What You Should Do

Check your prescription bottle of Cefdinir for Oral Suspension USP (250mg/5mL) for Lot Number F802335 and an expiration date of November 2020. This information is typically found on the side of the 60 mL bottle label.
Verify the National Drug Code (NDC) 68180-723-20 is printed on the label to ensure it matches the affected product.
Stop using the medication immediately if it matches the recalled lot and contact your healthcare provider or pharmacist to obtain a safe replacement or alternative treatment.
Return any unused portion of the affected medication to your pharmacy for a refund and further guidance on safe disposal.
Contact Lupin Pharmaceuticals Inc. for additional instructions or to report any issues related to this recall.
For further questions, 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 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, 250mg/5mL (60 mL bottle)

Model:

NDC 68180-723-20

Recall #: D-1320-2019

Lot Numbers:

F802335 (Exp November 2020)

Date Ranges: November 2020

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 82939

Status: Resolved

Manufacturer: Lupin Pharmaceuticals Inc.

Sold By: pharmacies

Manufactured In: India, United States

Units Affected: 18,408, 60 mL 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 · 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

What You Should Do

Check your prescription bottle of Cefdinir for Oral Suspension USP (250mg/5mL) for Lot Number F802335 and an expiration date of November 2020. This information is typically found on the side of the 60 mL bottle label.

Verify the National Drug Code (NDC) 68180-723-20 is printed on the label to ensure it matches the affected product.

Stop using the medication immediately if it matches the recalled lot and contact your healthcare provider or pharmacist to obtain a safe replacement or alternative treatment.

Return any unused portion of the affected medication to your pharmacy for a refund and further guidance on safe disposal.

Contact Lupin Pharmaceuticals Inc. for additional instructions or to report any issues related to this recall.

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