Home / Recalls / Shilpa Medicare Limited / D-0121-2021

D-0121-2021 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
2,064 vials

Product Description

Busulfan Injection 60 mg/10 mL (6 mg/mL), For Intravenous Infusion Only, Must be diluted before use, Single Dose Vial, Sterile, Cytotoxic Agent, Rx Only, 10 mL vial, Manufactured by: Shilpa Medicare Limited, India, Distributed by: Armas Pharmaceuticals, Inc., Manalapan, NJ 07726, Vial NDC 72485-210-01, Carton NDC 72485-210-08.

Reason for Recall

CGMP Deviations

Distribution Pattern

Nationwide in the U.S.

Code Information

Lot #: 7S10008B, Exp. 12/31/2020

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-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)
  • D-0122-2021 Class II — Azacitidine for Injection 100 mg/vial, For Subcutaneous and Intravenous Use Only (December 8, 2020)