FDA Drug recall D-1334-2022
Azacitidine for Injection 100mg/vial Lyophilized Powder, Rx Only, Mfd. in Romania By: Sindan Pharma SRL For BluePoint Laboratories, NDC 680…
- FDA Drug
- Class III
- terminated
- Published 2022-08-17
On 2022-08-17 the FDA classified a Class III recall of Azacitidine for Injection 100mg/vial Lyophilized Powder, Rx Only, Mfd. in Romania By: Sindan Pharma SRL For BluePoint Laboratories, NDC 680… by Teva Pharmaceuticals Usa, citing subpotent Drug - Out of specification (OOS) result obtained during monitoring stability study for Assay. Results below specification.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1334-2022 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2022-07-22 |
| Published | 2022-08-17 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Teva Pharmaceuticals Usa |
| Distribution | OH |
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.
Identifiers
| ndc | 68001-313-56 |
|---|---|
| code_info | Lot: FE22001A, Exp 01/2024 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
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All Teva Pharmaceuticals Usa recalls
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1334-2022%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.