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
Reported: December 23, 2020 Initiated: December 14, 2020 #D-0165-2021
Product Description
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
Reason for Recall
cGMP deviations: Vials may not be sealed correctly affecting sterility.
Details
- Recalling Firm
- CIPLA
- Units Affected
- 2151 vials
- Distribution
- USA Nationwide
- Location
- Warren, NJ
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by CIPLA. Units affected: 2151 vials.
Why was this product recalled? ▼
cGMP deviations: Vials may not be sealed correctly affecting sterility.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on December 23, 2020. Severity: Moderate. Recall number: D-0165-2021.
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