Recall archive / FDA drug enforcement
Azacitidine for Injection 100mg/vial Lyophilized Powder, Rx Only, Mfd. in Romania By: Sindan Pharma SRL For BluePoint... — FDA record D-1334-2022
Reported terminated
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Jul 22, 2022. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- Azacitidine for Injection 100mg/vial Lyophilized Powder, Rx Only, Mfd. in Romania By: Sindan Pharma SRL For BluePoint Laboratories, NDC 68001-313-56
- Reason
- Subpotent Drug - Out of specification (OOS) result obtained during monitoring stability study for Assay. Results below specification.
- Classification
- Class III
- Recalling firm
- Teva Pharmaceuticals USA Inc
- Quantity
- 4162 cartons
- Agency-reported status
- Terminated
- Source record identifier
- D-1334-2022
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | Lot: FE22001A, Exp 01/2024 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Distributed in Ohio
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
Dates in the source
- Report date
- Aug 17, 2022
- Recall initiation date
- Jul 22, 2022
- Center classification date
- Aug 11, 2022
- Termination date
- Apr 12, 2023
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.