Recalls / Class II
Class IID-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.
- Brand name
- Labetalol Hydrochloride
- Generic name
- Labetalol Hydrochloride
- Active ingredient
- Labetalol Hydrochloride
- Route
- Intravenous
- NDCs
- 0409-0125, 0409-2267
- FDA application
- ANDA075240
- Affected lot / code info
- Lots: a) 74370DD, Exp 1FEB2019; 75035DD, 75115DD, Exp 1MAR2019; b) 74230DD, Exp 1FEB2019
Why it was recalled
Defective Container: Cracked glass at the rim surface of glass vials, covered by the stopper and crimp seal.
Recalling firm
- Firm
- Hospira Inc. A Pfizer Company
- Manufacturer
- Hospira, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1776 Centennial Dr, N/A, Mcpherson, Kansas 67460-9301
Distribution
- Quantity
- a) 137,975 vials; b) 40,143 vials
- Distribution pattern
- Nationwide in the USA and Puerto Rico.
Timeline
- Recall initiated
- 2018-02-20
- FDA classified
- 2018-03-02
- Posted by FDA
- 2018-03-14
- Terminated
- 2020-04-02
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0576-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.