Drug product
Famotidine for Oral Suspension USP, 40 mg/5 mL, 50 mL bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202; Manufactured by: Lupin Limited, Goa 403 722 INDIA, NDC 68180-150-01
D-1127-2017
Product summary
- Event
- Event 78032
- Status
- Terminated
- Classification
- Class III
- Quantity
- 12,888 bottles
- Official record key
drug-enforcement:D-1127-2017
Official wording
Reason: CGMP Deviations
Code information: Lot #: G606950, Exp 07/18
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Manufacturing or process control
CGMP Deviations