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D-0124-2021 Class II Terminated

Recalled by Shilpa Medicare Limited — Polepally, Jadcherla, N/A

FDA drug recall D-0124-2021 was initiated by Shilpa Medicare Limited on December 8, 2020 and is designated Class II. Reason for recall: CGMP Deviations The recall status is terminated (terminated March 11, 2022). Affected quantity: 2611 bottles.

Recall Details

Product Type: Drugs
Report Date: December 16, 2020
Initiation Date: December 8, 2020
Termination Date: March 11, 2022
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 2611 bottles

Product Description

Imatinib Mesylate Tablets 100 mg, Rx Only, 90-count Bottle, Manufactured by: Shilpa Medicare Limited, India, Distributed by: Armas Pharmaceuticals Inc., Manalapan, NJ 07726, NDC 72485-202-90.

Reason for Recall

CGMP Deviations

Distribution Pattern

Nationwide in the U.S.

Code Information

Lot #s: 7S10033B, 7S10033A, 7S10031A, Exp. 02/28/2021.

Other recalls by Shilpa Medicare Limited

D-0125-2021 Class II — Imatinib Mesylate Tablets 400 mg, Rx Only, 30-count Bottle, Manufactured by: Shi (December 8, 2020)
D-0123-2021 Class II — Azacitidine for Injection 100 mg/vial, For Subcutaneous and Intravenous Use Only (December 8, 2020)
D-0122-2021 Class II — Azacitidine for Injection 100 mg/vial, For Subcutaneous and Intravenous Use Only (December 8, 2020)
D-0126-2021 Class II — Docetaxel Injection USP 160 mg/8mL (20 mg/mL), For Intravenous Infusion Only, Rx (December 8, 2020)
D-0121-2021 Class II — Busulfan Injection 60 mg/10 mL (6 mg/mL), For Intravenous Infusion Only, Must be (December 8, 2020)