Amlodipine Besylate USP 10 mg Tablets, 1000-count bottles, Rx Only, Manufactured by: Cipla Ltd., Verna Goa, India, Manufactured for: Cipla USA, Inc. 1560 Sawgrass Corporate Parkway, Suite 130, Sunrise FL 33323 UPC 369097128159, NDC 69097-128-15

Recall Number: D-0012-2019

Firm: InvaGen Pharmaceuticals, Inc.

Classification: Class III

Status: Terminated

Report Date: 20181017

Initiation Date: 20181003

Termination Date: 20210713

Subpotent Drug: One lot of product does not meet the product specification for Assay test at 3 month long term stability condition.

Amlodipine Besylate USP 10 mg Tablets, 1000-count bottles, Rx Only, Manufactured by: Cipla Ltd., Verna Goa, India, Manufactured for: Cipla USA, Inc. 1560 Sawgrass Corporate Parkway, Suite 130, Sunrise FL 33323 UPC 369097128159, NDC 69097-128-15