PlainRecalls
FDA Drug Moderate Class II Terminated

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.

Reported: April 19, 2017 Initiated: March 8, 2017 #D-0668-2017

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.

Details

Recalling Firm
Mckesson Medical Surgical
Units Affected
98 vials
Distribution
Nationwide in the USA
Location
Henrico, VA

Frequently Asked Questions

What product was recalled?
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.. Recalled by Mckesson Medical Surgical. Units affected: 98 vials.
Why was this product recalled?
Temperature Abuse: Certain pieces of these lots distributed by McKesson Medical Surgical Inc. were inadvertently stored refrigerated rather than the labeled room temperature recommendation.
Which agency issued this recall?
This recall was issued by the FDA Drug on April 19, 2017. Severity: Moderate. Recall number: D-0668-2017.