July 2022 FDA Recall Azacitidine by Teva Pharmaceuticals Usa Inc (D-1334-2022 - Subpotent Drug - Out of specification (OOS) result obtained during monitoring stability study for Assay. Results below specification.)

This Class III drug recall was voluntarily initiated by Teva Pharmaceuticals Usa Inc on July 22, 2022 for the product Azacitidine. The FDA reported the reason for recall as subpotent drug - out of specification (oos) result obtained during monitoring stability study for assay. results below specification.. The product was distributed in Distributed in Ohio and the recall is currently terminated.

Recall Number: D-1334-2022

Reason for Recall
Subpotent Drug - Out of specification (OOS) result obtained during monitoring stability study for Assay. Results below specification.
Initiated
07-22-2022
Reported
08-17-2022
Quantity
4162 cartons

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
90594
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Teva Pharmaceuticals USA Inc
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Distributed in Ohio
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-12-2023
Product Description About Product Description
Full technical description of the product.
Azacitidine for Injection 100mg/vial Lyophilized Powder, Rx Only, Mfd. in Romania By: Sindan Pharma SRL For BluePoint Laboratories, NDC 68001-313-56

Batch or Lot Expiration Information

Lot# Lot: FE22001A, Exp 01/2024

Affected Packages Involved in this Recall

68001-313-56 Azacitidine