Drug product
Cefdinir for Oral Suspension USP, 125 mg/5mL, packaged in a) 60 mL bottle (NDC 68180-722-20), b) 100 mL bottle (NDC 68180-722-10), Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202, United States, Manufactured by: Lupin Limited, Mandideep 462 046 INDIA
D-0306-2020
Product summary
- Event
- Event 84196
- Status
- Terminated
- Classification
- Class III
- Quantity
- a) 4074 bottles b) 30,300 bottles
- Official record key
drug-enforcement:D-0306-2020
Official wording
Reason: Presence of Foreign substance: identified as a dead ant.
Code information: Lot #: a) F900153, Exp 11/20; b) F802327, F802328, F802329, 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