FDA Drug recall D-1327-2015
Hydralazine Hydrochloride Injection, USP, 20 mg/mL, 1 mL fill, in a 2 mL
- FDA Drug
- Class III
- terminated
- Published 2015-08-19
On 2015-08-19 the FDA classified a Class III recall of Hydralazine Hydrochloride Injection, USP, 20 mg/mL, 1 mL fill, in a 2 mL by Fresenius Kabi Usa, citing incorrect Expiration Date: The "11/06" expiration date printed on the tray (secondary packaging) is incorrect (it should be 11/2016).
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1327-2015 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2015-07-28 |
| Published | 2015-08-19 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Fresenius Kabi Usa |
| Distribution | US |
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)
Identifiers
| ndc | 63323-614-00 |
|---|---|
| ndc | 63323-614-01 |
| code_info | Lot #: 6110593, Exp 11/2016 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1327-2015%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.