Fresenius Kabi USA, LLC recalls Hydralazine Hydrochloride Injection, USP, 20 mg/mL, 1 mL fill, in a 2 mL; single dose vial. Manufactured by Fresenius K…

Recall date

July 28, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-1327-2015

FDA classification

Class III

Brand / firm

Fresenius Kabi USA, LLC

Sold / distributed

Nationwide

Why it was recalled

Incorrect Expiration Date: The "11/06" expiration date printed on the tray (secondary packaging) is incorrect (it should be 11/2016)

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

Hydralazine Hydrochloride Injection, USP, 20 mg/mL, 1 mL fill, in a 2 mL; single dose vial. Manufactured by Fresenius Kabi USA 2020 N Ruby Street, Melrose Park, IL 60160-1112 for Fresenius Kabi USA, 3 Corporate Dr Lake Zurich, IL 60047-8930. NDC 63323-614-01