FDA-Drug2018-11-21Class II
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
Teva Pharmaceuticals USA
Hazard
Failed Impurities/Degradation Specifications; out-of-specification results for impurities obtained during routine stability testing
Sold states
Product was distributed throughout the United States, including Hawaii and Puerto Rico.
Affected count
1,362 vials
Manufactured in
1090 Horsham Rd, North Wales, PA, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0244-2019Don't want to check this manually?
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