Drug 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
D-0648-2024
Product summary
- Event
- Event 95193
- Status
- Terminated
- Classification
- Class II
- Quantity
- 4554 bottles
- Official record key
drug-enforcement:D-0648-2024
Official wording
Reason: Subpotent Drug- An out of specification ( OOS ) result observed in assay test during 18-month long term stability study.
Code information: Lot #: F201517, Exp 11/30/2024
Distribution pattern: USA nationwide.
Derived failure modes
-
Potency or specification failure
Subpotent