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, India
- Distributed byArmas Pharmaceuticals, Inc., Manalapan, NJ 07726, NDC 72606-558-01
- Lot codes and dates
Lot #: 7S10227AExp. 10/31/2021
- Amount recalled
- 6,560 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.
Free recall alerts
Get alerted about new Shilpa Medicare Limited recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.