Drug product
Cefixime for Oral Suspension USP 200 mg/5 mL (50 mL Pack size), Powder for oral suspension, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore Maryland, Manufactured by: Lupin Limited, Mandideep, India NDC 68180-407-03
D-0559-2024
Product summary
- Event
- Event 94723
- Status
- Terminated
- Classification
- Class II
- Quantity
- 3,552 bottles
- Official record key
drug-enforcement:D-0559-2024
Official wording
Reason: Failed Content Uniformity Specifications
Code information: Lot F201519, Expiry: November 2024
Distribution pattern: Nationwide in the US
Derived failure modes
-
Potency or specification failure
Failed Content Uniformity Specifications