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Recall Observatory FDA recall evidence

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

September 27, 2018

Class II

Product summary

Firm
Teva Pharmaceuticals USA
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

    reason.potency_specification_failure · v1.0.0

    out-of-specification