Class II · ModerateRecall completed
Azacitidine for Injection 100 mg/vial For Subcutaneous and Intravenous Use Only
Could cause temporary or reversible harm; serious harm is unlikely.
Does this affect you?
Check your lot numberLot #: 7S10182A, Ex 9/2021
Where it was soldUSA Nationwide
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.
What happened
cGMP deviations: Vials may not be sealed correctly affecting sterility.
What to do
- Check the lot number and expiry on your medicine against the recall above.
- Talk to your pharmacist or doctor before changing anything — don't stop on your own.
- Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).
Who makes it
Made byShilpa Medicare Limited Jadcherla -509301 INDIA Distributed by: Cipla USA, Inc. 10 Independence Blvd, Suite 300 Warren, NJ 07059 foreign manufacturer
| Distributed by / for | Cipla USA, Inc. 10 Independence Blvd, Suite 300 Warren, NJ 07059 |
| NDC | 69097-805-40 |
Show the full FDA record
| Full product label | Azacitidine for Injection 100 mg/vial For Subcutaneous and Intravenous Use Only Single-Dose Vial Manufactured by Shilpa Medicare Limited Jadcherla -509301 INDIA Distributed by: Cipla USA, Inc. 10 Independence Blvd, Suite 300 Warren, NJ 07059 NDC 69097-805-40 |
| Recalling firm | CIPLA |
| Distribution | USA Nationwide |
| Quantity | 2151 vials |
| Recall initiated | 2020-12-14 |
| Report date | 2020-12-23 |
| Recall completed | 2022-08-16 |
| Recall number | D-0165-2021 |
| Classification | Class II |
| FDA status | Terminated |
| Origin on file | Warren NJ United States |
Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗
This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.