Teva Pharmaceuticals USA Inc: Drug Recall

Recall #D-1334-2022 · 07/22/2022

Class III: Low Risk

Recall Details

Recall Number: D-1334-2022
Classification: Class III
Product Type: Drug
Recalling Firm: Teva Pharmaceuticals USA Inc
Status: Terminated
Date Initiated: 07/22/2022
Location: Parsippany, NJ, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 4162 cartons

Reason for Recall

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

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

Distribution Pattern

Distributed in Ohio

Other Recalls by Teva Pharmaceuticals USA Inc

Class III: Low Risk 11/07/2025

Defective Container - A defect in the side-seal which allows leakage of product.
Class II: Risk 10/13/2025

Subpotent drug; Clavulanate Potassium component
Class II: Risk 10/07/2025

CGMP Deviations-Test results for N-nitroso Prazosin impurity C that are above the Carcinogenic Potency Categorization Approach (CPCA) acceptable intake limit for the above specified lots.
Class II: Risk 10/07/2025

CGMP Deviations-Test results for N-nitroso Prazosin impurity C that are above the Carcinogenic Potency Categorization Approach (CPCA) acceptable intake limit for the above specified lots.
Class II: Risk 10/07/2025

CGMP Deviations-Test results for N-nitroso Prazosin impurity C that are above the Carcinogenic Potency Categorization Approach (CPCA) acceptable intake limit for the above specified lots.

View all recalls by Teva Pharmaceuticals USA Inc →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.