Azacitidine Injection, Powder, Lyophilized, For Solution
FDA Recall NDC 68001-313
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Azacitidine (NDC 68001-313). A significant event, classified as Class III, was initiated on Jul 22, 2022 by Bluepoint Laboratories. The reported reason for this action was: "Subpotent Drug - Out of specification (OOS) result obtained during monitoring stability study for Assay. Results below specification."
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
July 2022 Class III Recall: Subpotent Drug - Out of specification (OOS) result obtained during monitoring stability study for Assay. Results below specification.
Recall Number
Class III Terminated
Subpotent Drug - Out of specification (OOS) result obtained during monitoring stability study for Assay. Results below specification.
Jul 22, 2022
Aug 17, 2022
4162 cartons
Recall Profile & Regulatory Data
Event ID
90594
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Teva Pharmaceuticals USA Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Distributed in Ohio
Termination Date
Apr 12, 2023
Product Description
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
68001-313-56Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
