Teva Pharmaceuticals USA recalls Alprostadil Injection USP 500 micrograms/mL 1 mL single use vial, 5 vials per carton, Rx only, TEVA Pharmaceuticals USA,
Recalled November 21, 2018 · FDA recall D-0244-2019 · Teva Pharmaceuticals USA
Hazard
Failed Impurities/Degradation Specifications; out-of-specification results for impurities obtained during routine stability testing · FDA Class II
Units
1,362 vials
Sold at
Product was distributed throughout the United States, including Hawaii and Puerto Rico.
Description
Failed Impurities/Degradation Specifications; out-of-specification results for impurities obtained during routine stability testing
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
Manufacturer(s)
Teva Pharmaceuticals USA
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →