Reported Nov 21, 2018 · Terminated

Alprostadil Injection USP 500 micrograms/mL 1 mL single use vial, 5 vials per carton, Rx only, TEVA Pharmaceuticals…

Teva Pharmaceuticals USA

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Teva Pharmaceuticals USA · 1090 Horsham Rd · North Wales, PA · 19454-1505

Is this the product you have?

  • 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
Lot codes and dates
    • Lot # 31323147B
    • exp. date 01/2019
Amount recalled
1,362 vials

Where it was sold

Why it was recalled

Failed Impurities/Degradation Specifications; out-of-specification results for impurities obtained during routine stability testing

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Notice updated Oct 6, 2020 · Data as of Sep 19, 7:21 PM UTC

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