D-1327-2015 Class III Terminated
FDA drug recall D-1327-2015 was initiated by Fresenius Kabi USA, LLC on Jul 28, 2015 and is designated Class III. Reason for recall: Incorrect Expiration Date: The "11/06" expiration date printed on the tray (secondary packaging) is incorrect (it should be 11/2016) The recall status is terminated (terminated Mar 8, 2016). Affected quantity: 93,000 vials.
Recall Details
- Product Type
- Drugs
- Report Date
- Aug 19, 2015
- Initiation Date
- Jul 28, 2015
- Termination Date
- Mar 8, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 93,000 vials
Product Description
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)
Distribution Pattern
Nationwide
Code Information
Lot #: 6110593, Exp 11/2016
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-1327-2015
- openFDA file date
- Oct 27, 2026
- Loaded by RegDataLab
- Oct 29, 2026