Shilpa Medicare Limited: Drug Recall
Recall #D-0122-2021 · 12/08/2020
Class II: Risk
Recall Details
- Recall Number
- D-0122-2021
- Classification
- Class II
- Product Type
- Drug
- Recalling Firm
- Shilpa Medicare Limited
- Status
- Terminated
- Date Initiated
- 12/08/2020
- Location
- Polepally, Jadcherla, N/A, India
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 35,931 vials
Reason for Recall
CGMP Deviations
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.
Distribution Pattern
Nationwide in the U.S.
Other Recalls by Shilpa Medicare Limited
- Class II: Risk 12/08/2020
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.