Drug product
Cefdinir for Oral Suspension USP 250 mg/5 mL (60 mL when reconstituted), 60 mL bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202, United States, Manufactured by: Lupin Limited, Mandideep 462 046, India, NDC 68180-723-04
D-0496-2024
Product summary
- Event
- Event 94492
- Status
- Terminated
- Classification
- Class II
- Quantity
- 17,070 bottles
- Official record key
drug-enforcement:D-0496-2024
Official wording
Reason: Presence of foreign substance: Product complaint of foreign material in reconstituted bottle.
Code information: Lot # F305442, Exp 8/30/2025
Distribution pattern: USA nationwide
Derived failure modes
-
Foreign material or chemical contamination
foreign substance