FDAClass IIMarch 14, 2018

Labetalol Hydrochloride Injection recall

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…

Why was Labetalol Hydrochloride Injection recalled?

Defective Container: Cracked glass at the rim surface of glass vials, covered by the stopper and crimp seal.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

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…
Recalling firm
Hospira Inc. A Pfizer Company
Quantity
a) 137,975 vials; b) 40,143 vials
Distribution
Nationwide in the USA and Puerto Rico.
Recall date
March 14, 2018
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls