Azacitidine for Injection 100mg/vial Lyophilized Powder, Rx Only, Mfd. in Romania By: Sindan Pharma SRL For BluePoint Laboratories, NDC 68001-313-56

FDA recall notice · announced August 17, 2022 · Teva Pharmaceuticals

Class III FDA/FSIS Class III: use is not likely to cause adverse health consequences.

The product

Reason for recall

Subpotent Drug - Out of specification (OOS) result obtained during monitoring stability study for Assay. Results below specification.

Notes

Distribution: Distributed in Ohio
Lot/code information: Lot: FE22001A, Exp 01/2024
Quantity: 4162 cartons
Status: Terminated
Products in this recall event:
- Azacitidine for Injection 100mg/vial Lyophilized Powder, Rx Only, Mfd. in Romania By: Sindan Pharma SRL For BluePoint Laboratories, NDC 68001-313-56 (D-1334-2022)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.