D-1424-2014 Class II Terminated
FDA drug recall D-1424-2014 was initiated by Hospira Inc. on May 16, 2014 and is designated Class II. Reason for recall: Presence of Particulate Matter; metal embedded in the glass vial and visible particles floating in the solution The recall status is terminated (terminated Mar 16, 2017). Affected quantity: 45,448 vials.
Recall Details
- Product Type
- Drugs
- Report Date
- Jul 16, 2014
- Initiation Date
- May 16, 2014
- Termination Date
- Mar 16, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 45,448 vials
Product Description
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
Reason for Recall
Presence of Particulate Matter; metal embedded in the glass vial and visible particles floating in the solution
Distribution Pattern
Nationwide
Code Information
Lot 36225DD, exp 12/01/2015
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-1424-2014
- openFDA file date
- Oct 27, 2026
- Loaded by RegDataLab
- Oct 29, 2026