Recall
FDAHealthAugust 21, 2024

Lupin Pharmaceuticals Inc. — Cefixime for Oral Suspension USP, 100 mg/5 mL, 50 mL bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202, Manufactured by: Lupin Limi

⚠️ Subpotent Drug- An out of specification ( OOS ) result observed in assay test during 18-month long term stability study.

Is this relevant to me?

Geography
Nationwide
Source agency
FDA
Category
Health
Published
August 21, 2024

USA nationwide.

What's affected?

Product
Cefixime for Oral Suspension USP, 100 mg/5 mL, 50 mL bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202, Manufactured by: Lupin Limited, Mandideep 462 046 INDIA, NDC 68180-405-01
UPC
0368180423089
Lot code
F201517

Additional details

Lot #: F201517, Exp 11/30/2024

What should I do?

Recommended action

Class II recall. Voluntary: Firm initiated Quantity affected: 4554 bottles.

View original FDA notice →

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