Drug recall D-1327-2015

Class III Terminated reported Aug 19, 2015

Product

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

Reason for recall

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

Lots and codes

Lot #: 6110593, Exp 11/2016

Recall details

Recalling firm
Fresenius Kabi USA, LLC, Lake Zurich, IL
Quantity
93,000 vials
Distribution
Nationwide
Type
Voluntary: Firm initiated
Recall initiated
July 28, 2015
Terminated
March 8, 2016

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