Imatinib Mesylate Tablets 400 mg, Rx Only, 30-count Bottle, Manufactured by: Shilpa Medicare Limited, India, Distributed by: Armas Pharmaceuticals Inc., Manalapan, NJ 07726, NDC 72485-203-30.

Recall Number: D-0125-2021

Firm: Shilpa Medicare Limited

Classification: Class II

Status: Terminated

Report Date: 20201216

Initiation Date: 20201208

Termination Date: 20220311

CGMP Deviations

Imatinib Mesylate Tablets 400 mg, Rx Only, 30-count Bottle, Manufactured by: Shilpa Medicare Limited, India, Distributed by: Armas Pharmaceuticals Inc., Manalapan, NJ 07726, NDC 72485-203-30.