Drug product
Cefdinir for Oral Suspension USP, 250 mg/5mL,100 mL bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202, United States, Manufactured by: Lupin Limited, Mandideep 462 046 INDIA, NDC 68180-723-10
D-0305-2020
Product summary
- Event
- Event 84196
- Status
- Terminated
- Classification
- Class III
- Quantity
- 30,516 bottles
- Official record key
drug-enforcement:D-0305-2020
Official wording
Reason: Presence of Foreign substance: identified as a dead ant.
Code information: Lot #: F802345, F802346, F802347, Exp 11/20
Distribution pattern: Product was distributed to major distributors/wholesalers throughout the United States.
Derived failure modes
-
Foreign material or chemical contamination
Foreign substance