Recalls / Class II
Class IID-1424-2014
Product
Labetalol Hydrochloride Injection, USP, 100 mg/20 mL (5 mg/mL), 20 mL Multidose Vial, packaged 50/20 mL glass vials/carton, Hospira, Inc., Lake Forest, IL 60045 --- NDC 0409-2267-20
- 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
- Lot 36225DD, exp 12/01/2015
Why it was recalled
Presence of Particulate Matter; metal embedded in the glass vial and visible particles floating in the solution
Recalling firm
- Firm
- Hospira Inc.
- Manufacturer
- Hospira, Inc.
- Notification channel
- Press Release
- Type
- Voluntary: Firm initiated
- Address
- 275 N Field Dr, Lake Forest, Illinois 60045-2579
Distribution
- Quantity
- 45,448 vials
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2014-05-16
- FDA classified
- 2014-07-08
- Posted by FDA
- 2014-07-16
- Terminated
- 2017-03-16
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1424-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.