Drug recall D-0576-2018
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.
Reason for recall
Defective Container: Cracked glass at the rim surface of glass vials, covered by the stopper and crimp seal.
Lots and codes
Lots: a) 74370DD, Exp 1FEB2019; 75035DD, 75115DD, Exp 1MAR2019; b) 74230DD, Exp 1FEB2019
Recall details
- Recalling firm
- Hospira Inc. A Pfizer Company, Mcpherson, KS
- Quantity
- a) 137,975 vials; b) 40,143 vials
- Distribution
- Nationwide in the USA and Puerto Rico.
- Type
- Voluntary: Firm initiated
- Recall initiated
- February 20, 2018
- Terminated
- April 2, 2020
Related products
- Labetalol Hydrochloride – drug information
- NDC 0409-0125 Labetalol Hydrochloride · Labetalol Hydrochloride 5 mg/mL · Hospira, Inc.