Drug product
Azacitidine for Injection, 100 mg Lyophilized Powder, Single-Dose Vials, Rx Only, Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213 India. Manufactured for BluePoint Laboratories. NDC 68001-0313-56
D-1349-2022
Product summary
- Event
- Event 90677
- Status
- Terminated
- Classification
- Class III
- Quantity
- 4,160 vials
- Official record key
drug-enforcement:D-1349-2022
Official wording
Reason: Subpotent Drug
Code information: Lot #: FE22001A, Exp. Date 01/2024
Distribution pattern: Nationwide within the USA
Derived failure modes
-
Potency or specification failure
Subpotent