Drug product
Cephalexin for Oral Suspension USP, 250mg/5mL, 200 mL (when mixed), Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland, Manufactured by: Lupin Limited, Mandideep, India ---- NDC 68180-0124-02
D-0380-2019
Product summary
- Event
- Event 81898
- Status
- Terminated
- Classification
- Class II
- Quantity
- 7,215 bottles
- Official record key
drug-enforcement:D-0380-2019
Official wording
Reason: CGMP Deviation; manufacturing batch record could not be located
Code information: lot # F602820, Expiry December 2019
Distribution pattern: Product was distributed to 12 major distributors who may have further distributed the product throughout the United States.
Derived failure modes
-
Manufacturing or process control
CGMP Deviation