D-0576-2018 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- March 14, 2018
- Initiation Date
- February 20, 2018
- Termination Date
- April 2, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- a) 137,975 vials; b) 40,143 vials
Product Description
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.
Reason for Recall
Defective Container: Cracked glass at the rim surface of glass vials, covered by the stopper and crimp seal.
Distribution Pattern
Nationwide in the USA and Puerto Rico.
Code Information
Lots: a) 74370DD, Exp 1FEB2019; 75035DD, 75115DD, Exp 1MAR2019; b) 74230DD, Exp 1FEB2019