D-0988-2022 Class III Terminated
FDA drug recall D-0988-2022 was initiated by Teva Pharmaceuticals USA Inc on May 18, 2022 and is designated Class III. Reason for recall: Failed Impurities/Degradation Specifications; out-of-specification results for impurities obtained during routine stability testing The recall status is terminated (terminated Dec 8, 2023). Affected quantity: 3109 cartons.
Recall Details
- Product Type
- Drugs
- Report Date
- Jun 15, 2022
- Initiation Date
- May 18, 2022
- Termination Date
- Dec 8, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3109 cartons
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
Reason for Recall
Failed Impurities/Degradation Specifications; out-of-specification results for impurities obtained during routine stability testing
Distribution Pattern
Product was distributed nationwide in the US Market
Code Information
Lot #:100022404, Exp Date 10/2022; Lot #:100023333, Exp Dat 12/2022
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0988-2022
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026