Drug product
Amlodipine Besylate Tablets USP, 2.5mg, 90-count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, Manufactured by: Lupin Limited Goa 403 722 INDIA, NDC 68180-750-09
D-1492-2016
Product summary
- Firm
- Lupin Limited
- Event
- Event 74964
- Status
- Terminated
- Classification
- Class III
- Quantity
- 43,536 bottles
- Official record key
drug-enforcement:D-1492-2016
Official wording
Reason: CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications.
Code information: Lot #: G304799, Exp. 4/2016
Distribution pattern: US No recalled product was distributed to any foreign consignees by Lupin.
Derived failure modes
-
Manufacturing or process control
CGMP Deviations