Recall: D-1327-2015

Class III - Minor Violations

Class IIIClassification

2015-07-28Initiated

TerminatedStatus

Fresenius Kabi USA, LLCFirm

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

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

Distribution

Nationwide

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.