Recall: D-0122-2021
Class II - Potentially Harmful
Class IIClassification
2020-12-08Initiated
TerminatedStatus
Shilpa Medicare LimitedFirm
Product
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
CGMP Deviations
Distribution
Nationwide in the U.S.
Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.