March 2017 FDA Recall Hydralazine Hydrochloride by Mckesson Medical Surgical
D-0668-2017 - Temperature Abuse

This Class II drug recall was voluntarily initiated by Mckesson Medical Surgical on March 8, 2017 for the product Hydralazine Hydrochloride. The FDA reported the reason for recall as temperature abuse. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0668-2017

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.
Initiated
03-08-2017
Reported
04-19-2017
Quantity
98 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
76863
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Mckesson Medical Surgical
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
08-19-2024
Product Description About Product Description
Full technical description of the 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.

Batch or Lot Expiration Information

Lot# s: 6114311, 6114717, Exp 05/18

Affected Packages Involved in this Recall

63323-614-00 Hydralazine Hydrochloride
63323-614-01 Hydralazine Hydrochloride