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
Reported: July 16, 2014 Initiated: May 16, 2014 #D-1424-2014
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
Details
- Recalling Firm
- Hospira Inc.
- Units Affected
- 45,448 vials
- Distribution
- Nationwide
- Location
- Lake Forest, IL
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Hospira Inc.. Units affected: 45,448 vials.
Why was this product recalled? ▼
Presence of Particulate Matter; metal embedded in the glass vial and visible particles floating in the solution
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on July 16, 2014. Severity: Moderate. Recall number: D-1424-2014.
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