Drug recall D-1334-2022

Class III Terminated reported Aug 17, 2022

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 for recall

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

Lots and codes

Lot: FE22001A, Exp 01/2024

Recall details

Recalling firm
Teva Pharmaceuticals USA Inc, Parsippany, NJ
Quantity
4162 cartons
Distribution
Distributed in Ohio
Type
Voluntary: Firm initiated
Recall initiated
July 22, 2022
Terminated
April 12, 2023

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