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
- Brand
- CEFIXIME
- 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.
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