Drug product
Cefdinir for Oral Suspension USP, 250 mg/5 mL, packaged in a 60 mL bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, MD 21202, Manufactured by: Lupin Limited, Mandideep, 462 046 India, NDC 68180-723-04
D-0518-2024
Product summary
- Event
- Event 94602
- Status
- Terminated
- Classification
- Class II
- Quantity
- 51,006 bottles
- Official record key
drug-enforcement:D-0518-2024
Official wording
Reason: Defective container: lack of seal integrity.
Code information: Lot #F305184, F305185, F305186, Exp 7/31/ 2025
Distribution pattern: USA Nationwide
Derived failure modes
-
Unknown
Defective container: lack of seal integrity.