Home / Recalls / Shilpa Medicare Limited / D-0122-2021

D-0122-2021 Class II Terminated

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

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
35,931 vials

Product Description

Azacitidine for Injection 100 mg/vial, For Subcutaneous and Intravenous Use Only, Rx Only, One Single Dose Vial, Cytotoxic Agent, Manufactured by: Shilpa Medicare Limited, Jadcherla, 509301, India, Distributed by: Armas Pharmaceuticals, Inc. Manalapan, NJ 07726 NDC 72485-201-01.

Reason for Recall

CGMP Deviations

Distribution Pattern

Nationwide in the U.S.

Code Information

Lot #s: 7S10115A, Exp. 07/31/2021; 7S10143A, 7S10182B, Exp. 09/30/2021; 7S10255A, 7S10256A, 7S10263A, Exp. 11/30/2021; 7T10028A, 12/31/2021; 7T10040A, Exp. 01/31/2022.

Other recalls by Shilpa Medicare Limited

  • D-0121-2021 Class II — Busulfan Injection 60 mg/10 mL (6 mg/mL), For Intravenous Infusion Only, Must be (December 8, 2020)
  • D-0125-2021 Class II — Imatinib Mesylate Tablets 400 mg, Rx Only, 30-count Bottle, Manufactured by: Shi (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-0123-2021 Class II — Azacitidine for Injection 100 mg/vial, For Subcutaneous and Intravenous Use Only (December 8, 2020)
  • D-0124-2021 Class II — Imatinib Mesylate Tablets 100 mg, Rx Only, 90-count Bottle, Manufactured by: Shi (December 8, 2020)