FDAFDA · Food and drugs·Recall number D-0576-2018
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.
Published March 14, 2018 · Recall initiated: February 20, 2018
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Defective Container: Cracked glass at the rim surface of glass vials, covered by the stopper and crimp seal.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- LABETALOL HYDROCHLORIDE
- Manufacturer
- Hospira Inc. A Pfizer Company
- Distributor
- Nationwide in the USA and Puerto Rico.
- Lot
- Lots: a) 74370DD, Exp 1FEB2019; 75035DD, 75115DD, Exp 1MAR2019; b) 74230DD, Exp 1FEB2019
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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