February 2018 FDA Recall Labetalol Hydrochloride by Hospira Inc. A Pfizer Company
D-0576-2018 - Defective Container

This Class II drug recall was voluntarily initiated by Hospira Inc. A Pfizer Company on February 20, 2018 for the product Labetalol Hydrochloride. The FDA reported the reason for recall as defective container. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0576-2018

Reason for Recall
Defective Container: Cracked glass at the rim surface of glass vials, covered by the stopper and crimp seal.
Initiated
02-20-2018
Reported
03-14-2018
Quantity
a) 137,975 vials; b) 40,143 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
79238
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. A Pfizer Company
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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide in the USA and Puerto Rico.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-02-2020
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, Rx only, labeled as a) Hospira, Inc., Lake Forest, IL 60045, NDC 0409-2267-20; and b) NOVAPLUS, Manufactured by Hospira, Inc., Lake Forest, IL 60045, NDC 0409-2267-25.

Batch or Lot Expiration Information

Lot# Lots: a) 74370DD, Exp 1FEB2019; 75035DD, 75115DD, Exp 1MAR2019; b) 74230DD, Exp 1FEB2019

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
0409-2267-25 Labetalol Hydrochloride