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

FDA recall notice · announced November 21, 2018 · Teva Pharmaceuticals

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The 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

Reason for recall

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

Notes

Distribution: Product was distributed throughout the United States, including Hawaii and Puerto Rico.
Lot/code information: Lot # 31323147B, exp. date 01/2019
Quantity: 1,362 vials
Status: Terminated
Products in this recall event:
- 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)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.