Drug product
Alprostadil Injection USP 500 micrograms/mL 1 mL single use vial, 5 vials per carton, Rx only, TEVA Pharmaceuticals USA, Inc., North Wales, PA --- NDC 0703-1501-02
D-0244-2019
Product summary
- Event
- Event 81120
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1,362 vials
- Official record key
drug-enforcement:D-0244-2019
Official wording
Reason: Failed Impurities/Degradation Specifications; out-of-specification results for impurities obtained during routine stability testing
Code information: Lot # 31323147B, exp. date 01/2019
Distribution pattern: Product was distributed throughout the United States, including Hawaii and Puerto Rico.
Derived failure modes
-
Potency or specification failure
out-of-specification