FDA recall D-0668-2017

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 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

Nationwide in the USA

Key facts

Status

Terminated

Initiation date

2017-03-08

Report date

2017-04-19

Termination date

2024-08-19

Voluntary/Mandated

Voluntary: Firm initiated

Location

Henrico, VA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0668-2017