FDA Drug recall D-0668-2017
hydrALAZINE HYDROCHLORIDE INJECTION, USP, 20 mg/mL, 1 mL Single Dose Vial, packaged in 25 Vials per carton, Rx only, APP Fresenius Kabi USA…
- FDA Drug
- Class II
- terminated
- Published 2017-04-19
On 2017-04-19 the FDA classified a Class II recall of hydrALAZINE HYDROCHLORIDE INJECTION, USP, 20 mg/mL, 1 mL Single Dose Vial, packaged in 25 Vials per carton, Rx only, APP Fresenius Kabi USA… by Mckesson Medical Surgical, citing temperature Abuse: Certain pieces of these lots distributed by McKesson Medical Surgical Inc. were inadvertently stored refrigerated rather than the labeled room temperature recom….
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0668-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-03-08 |
| Published | 2017-04-19 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Mckesson Medical Surgical |
| Distribution | US |
Product
hydrALAZINE HYDROCHLORIDE INJECTION, USP, 20 mg/mL, 1 mL Single Dose Vial, packaged in 25 Vials per carton, Rx only, APP Fresenius Kabi USA, LLC, Lake Surich, IL 60047, NDC 63323-614-01, Distributed by McKesson Medical-Surgical, Inc.
Reason
Temperature Abuse: Certain pieces of these lots distributed by McKesson Medical Surgical Inc. were inadvertently stored refrigerated rather than the labeled room temperature recommendation.
Identifiers
| ndc | 63323-614-00 |
|---|---|
| ndc | 63323-614-01 |
| code_info | Lot #s: 6114311, 6114717, Exp 05/18 |
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-0668-2017%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.