D-1493-2016 Class III Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- September 14, 2016
- Initiation Date
- February 19, 2016
- Termination Date
- April 3, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 11,812 bottles
Product Description
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
Reason for Recall
CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications.
Distribution Pattern
US No recalled product was distributed to any foreign consignees by Lupin.
Code Information
Lot #: G304677, G304540, G304536, G304537, G304535, G304541, G304545, G304533, G304532, G304539, G304538, G304534, Exp. 4/2016