Teva Pharmaceuticals USA Inc: Drug Recall

Recall #D-0988-2022 · 05/18/2022

Class III: Low Risk

Recall Details

Recall Number: D-0988-2022
Classification: Class III
Product Type: Drug
Recalling Firm: Teva Pharmaceuticals USA Inc
Status: Terminated
Date Initiated: 05/18/2022
Location: Parsippany, NJ, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 3109 cartons

Reason for Recall

Failed Impurities/Degradation Specifications; out-of-specification results for impurities obtained during routine stability testing

Product Description

Alprostadil Injection USP 500 mcg/mL, 1 mL Single Dose Vial, 5 vials per Carton, Rx Only, Carton NDC 0703-1501-02, Distributed by: Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054, Vial NDC 0703-1501-01

Distribution Pattern

Product was distributed nationwide in the US Market

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.