Drug product
Cephalexin for Oral Suspension USP, 250 mg/5mL, 200 mL bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc. 111 South Calvert Street, Baltimore, Maryland 21202, United States, Manufactured by: Lupin Limited, Mumbai 400 098 INDIA, NDC 68180-0441-02
D-0304-2020
Product summary
- Event
- Event 84196
- Status
- Terminated
- Classification
- Class III
- Quantity
- 28,254 bottles
- Official record key
drug-enforcement:D-0304-2020
Official wording
Reason: Presence of Foreign substance: identified as a dead ant.
Code information: Lot #: F802436, F802437, F802438, F802442, 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