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

Recall Number: D-1492-2016

Firm: Lupin Limited

Classification: Class III

Status: Terminated

Report Date: 20160914

Initiation Date: 20160219

Termination Date: 20170403

CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications.

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