May 2014 FDA Recall Labetalol Hydrochloride by Hospira Inc.
D-1424-2014 - Presence of Particulate Matter; metal embedded in the glass vial and visible particles floating in the solution

This Class II drug recall was voluntarily initiated by Hospira Inc. on May 16, 2014 for the product Labetalol Hydrochloride. The FDA reported the reason for recall as presence of particulate matter; metal embedded in the glass vial and visible particles floating in the solution. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-1424-2014

Reason for Recall
Presence of Particulate Matter; metal embedded in the glass vial and visible particles floating in the solution
Initiated
05-16-2014
Reported
07-16-2014
Quantity
45,448 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
68296
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.
Hospira Inc.
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.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-16-2017
Product Description About Product Description
Full technical description of the product.
Labetalol Hydrochloride Injection, USP, 100 mg/20 mL (5 mg/mL), 20 mL Multidose Vial, packaged 50/20 mL glass vials/carton, Hospira, Inc., Lake Forest, IL 60045 --- NDC 0409-2267-20

Batch or Lot Expiration Information

Lot# Lot 36225DD, exp 12/01/2015

Affected Packages Involved in this Recall

0409-2267-20 Labetalol Hydrochloride
0409-2267-54 Labetalol Hydrochloride
0409-0125-01 Labetalol Hydrochloride
0409-0125-25 Labetalol Hydrochloride