Drug 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.
D-0576-2018
Product summary
- Event
- Event 79238
- Status
- Terminated
- Classification
- Class II
- Quantity
- a) 137,975 vials; b) 40,143 vials
- Official record key
drug-enforcement:D-0576-2018
Official wording
Reason: Defective Container: Cracked glass at the rim surface of glass vials, covered by the stopper and crimp seal.
Code information: Lots: a) 74370DD, Exp 1FEB2019; 75035DD, 75115DD, Exp 1MAR2019; b) 74230DD, Exp 1FEB2019
Distribution pattern: Nationwide in the USA and Puerto Rico.
Derived failure modes
-
Unknown
Defective Container: Cracked glass at the rim surface of glass vials, covered by the stopper and crimp seal.