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Recall Observatory FDA recall evidence

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

May 18, 2022

Class III

Product summary

Firm
Teva Pharmaceuticals USA Inc
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

    reason.potency_specification_failure · v1.0.0

    out-of-specification