Drug product
Amlodipine Besylate Tablets USP, 10mg, 1000-count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, Manufactured by: Lupin Limited Goa 403 722 INDIA, NDC 68180-752-03
D-1493-2016
Product summary
- Firm
- Lupin Limited
- Event
- Event 74964
- Status
- Terminated
- Classification
- Class III
- Quantity
- 11,812 bottles
- Official record key
drug-enforcement:D-1493-2016
Official wording
Reason: CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications.
Code information: Lot #: G304677, G304540, G304536, G304537, G304535, G304541, G304545, G304533, G304532, G304539, G304538, G304534, 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