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.
Reported: December 16, 2020 Initiated: December 8, 2020 #D-0122-2021
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
Details
- Recalling Firm
- Shilpa Medicare Limited
- Units Affected
- 35,931 vials
- Distribution
- Nationwide in the U.S.
- Location
- Polepally, Jadcherla, N/A
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Shilpa Medicare Limited. Units affected: 35,931 vials.
Why was this product recalled? ▼
CGMP Deviations
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on December 16, 2020. Severity: Moderate. Recall number: D-0122-2021.
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