Drug product
1% LIDOCAINE HCl Injection, USP, 10 mg/mL, 30 mL Single-dose, Preservative-Free glass vial (Twenty-five (25) units per box/fifty (50) units per case, NDC 0409-4279-02, Hospira, Inc., Lake Forest, IL 60045
D-0391-2015
Product summary
- Firm
- Hospira Inc.
- Event
- Event 69567
- Status
- Terminated
- Classification
- Class I
- Quantity
- 100,100 units
- Official record key
drug-enforcement:D-0391-2015
Official wording
Reason: Presence of particulate matter: A returned customer sample was evaluated and found to have human hair attached to a pinched area of the stopper.
Code information: Lot# 40-316-DK, Exp 01APR2016
Distribution pattern: Nationwide
Derived failure modes
-
Foreign material or chemical contamination
particulate matter