D-0742-2021 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- August 25, 2021
- Initiation Date
- July 29, 2021
- Termination Date
- June 4, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2,199 vials
Product Description
Alprostadil Injection USP, 500 mg/mL, 1 mL single dose, vials, 5 mL single use vial per carton (NDC 0703-1501-02), Rx only, Teva Pharmaceuticals USA, Inc. Parsippany, NJ 07054, Vial NDC 0703-1501-01
Reason for Recall
Lack of Assurance of Sterility
Distribution Pattern
Product was distributed Nationwide, including Puerto Rico.
Code Information
Lot #: 31329295B, exp date. 01/2022