Class II · Moderate risk Ongoing
Azacitidine for Injection 100mg/Vial, 1 10 mL Single-Dose Vial per carton, For Subcutaneous and Intravenous Use, Rx only…
Reason Lack of Sterility Assurance
Azacitidine for Injection 100mg/vial Lyophilized Powder, Rx Only, Mfd. in Romania By…
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Subpotent Drug - Out of specification (OOS) result obtained during monitoring stability study for Assay. Results below specification.
What was recalled
Azacitidine for Injection 100mg/vial Lyophilized Powder, Rx Only, Mfd. in Romania By: Sindan Pharma SRL For BluePoint Laboratories, NDC 68001-313-56
- Recalling firm
- Teva Pharmaceuticals USA Inc
- NDC code
- 68001-313-56
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1334-2022
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Other Azacitidine recalls
See all
Class III · Low risk Terminated
Azacitidine for Injection, 100 mg Lyophilized Powder, Single-Dose Vials, Rx Only, Manufactured by: Intas Pharmaceuticals…
Reason Subpotent Drug
Class III · Low risk Terminated
Azacitidine, 100mg/vial, One Single-dose Vial, Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited, Visakhapatnam - 530 046…
Reason Failed stability specifications
Class III · Low risk Terminated
Azacitidine, 1,00mg/Vial, One Single-dose Vial, Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited, Visakhapatnam - 530 046…
Reason Failed stability specifications
Class II · Moderate risk Terminated
Azacitidine for Injection 100 mg/vial For Subcutaneous and Intravenous Use Only Single-Dose Vial Manufactured by Shilpa Medicare…
Reason cGMP deviations: Vials may not be sealed correctly affecting sterility.
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