Reported Dec 16, 2020 · Terminated
Azacitidine for Injection 100 mg/vial, For Subcutaneous and Intravenous Use Only, Rx Only, One Single Dose Vial,…
Shilpa Medicare Limited
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Shilpa Medicare Limited · S-20 To S-26, Pharm. Formulation Sez · Polepally, Jadcherla, N/A · N/A
Is this the product you have?
- Azacitidine for Injection 100 mg/vial, For Subcutaneous and Intravenous Use Only, Rx Only, One Single Dose Vial, Cytotoxic Agent
- Manufactured byShilpa Medicare Limited, Jadcherla, 509301, India
- Distributed byArmas Pharmaceuticals, Inc. Manalapan, NJ 07726 NDC 72485-201-01
- Lot codes and dates
Lot #s: 7S10115AExp. 07/31/20217S10143A7S10182BExp. 09/30/20217S10255A7S10256A7S10263AExp. 11/30/20217T10028A12/31/20217T10040AExp. 01/31/2022
- Amount recalled
- 35,931 vials
This recall covers 6 products
The agency filed one notice per product. You are reading one of them; the other 5 are below.
Where it was sold
- Nationwide
Why it was recalled
CGMP Deviations
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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