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

D-0122-2021 Class II Terminated

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

FDA drug recall D-0122-2021 was initiated by Shilpa Medicare Limited on Dec 8, 2020 and is designated Class II. Reason for recall: CGMP Deviations The recall status is terminated (terminated Mar 11, 2022). Affected quantity: 35,931 vials.

Recall Details

Product Type: Drugs
Report Date: Dec 16, 2020
Initiation Date: Dec 8, 2020
Termination Date: Mar 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.

Source

Dataset: openFDA drug recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for D-0122-2021
openFDA file date: Nov 3, 2026
Loaded by RegDataLab: Nov 4, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.

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