Drug product
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
D-0988-2022
Product summary
- Event
- Event 90239
- Status
- Terminated
- Classification
- Class III
- Quantity
- 3109 cartons
- Official record key
drug-enforcement:D-0988-2022
Official wording
Reason: Failed Impurities/Degradation Specifications; out-of-specification results for impurities obtained during routine stability testing
Code information: Lot #:100022404, Exp Date 10/2022; Lot #:100023333, Exp Dat 12/2022
Distribution pattern: Product was distributed nationwide in the US Market
Derived failure modes
-
Potency or specification failure
out-of-specification