D-0668-2017 Class II Terminated
FDA drug recall D-0668-2017 was initiated by Mckesson Medical Surgical on Mar 8, 2017 and is designated Class II. Reason for recall: Temperature Abuse: Certain pieces of these lots distributed by McKesson Medical Surgical Inc. were inadvertently stored refrigerated rather than the labeled room temperature recommendation. The recall status is terminated (terminated Aug 19, 2024). Affected quantity: 98 vials.
Recall details
- Product Type
- Drugs
- Report Date
- Apr 19, 2017
- Initiation Date
- Mar 8, 2017
- Termination Date
- Aug 19, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 98 vials
Product description
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 for recall
Temperature Abuse: Certain pieces of these lots distributed by McKesson Medical Surgical Inc. were inadvertently stored refrigerated rather than the labeled room temperature recommendation.
Distribution pattern
Nationwide in the USA
Code information
Lot #s: 6114311, 6114717, Exp 05/18
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0668-2017
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026