Drug 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
D-1327-2015
Product summary
- Event
- Event 71827
- Status
- Terminated
- Classification
- Class III
- Quantity
- 93,000 vials
- Official record key
drug-enforcement:D-1327-2015
Official wording
Reason: Incorrect Expiration Date: The "11/06" expiration date printed on the tray (secondary packaging) is incorrect (it should be 11/2016)
Code information: Lot #: 6110593, Exp 11/2016
Distribution pattern: Nationwide
Derived failure modes
-
Unknown
Incorrect Expiration Date: The "11/06" expiration date printed on the tray (secondary packaging) is incorrect (it should be 11/2016)