Drug product
Cefixime for Oral Suspension 100mg/5mL, 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-0274-2024
Product summary
- Event
- Event 93730
- Status
- Terminated
- Classification
- Class II
- Quantity
- 4,608 Bottles
- Official record key
drug-enforcement:D-0274-2024
Official wording
Reason: Failed Impurities/Degradation Specifications
Code information: Lot #: F304833, Exp 06/2025
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Potency or specification failure
Failed Impurities/Degradation Specifications