Drug 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
D-1424-2014
Product summary
- Firm
- Hospira Inc.
- Event
- Event 68296
- Status
- Terminated
- Classification
- Class II
- Quantity
- 45,448 vials
- Official record key
drug-enforcement:D-1424-2014
Official wording
Reason: Presence of Particulate Matter; metal embedded in the glass vial and visible particles floating in the solution
Code information: Lot 36225DD, exp 12/01/2015
Distribution pattern: Nationwide
Derived failure modes
-
Foreign material or chemical contamination
Particulate Matter