Drug product
Lidocaine HCl Injection, USP, 2%, 20 mg per mL, packaged in 5-mL single-dose vials, 10 vials per box, Rx Only, Hospira, Inc., Lake Forest, IL. 60045, NDC 0409-2066-05.
D-1278-2014
Product summary
- Firm
- Hospira Inc.
- Event
- Event 67140
- Status
- Terminated
- Classification
- Class I
- Quantity
- 68,350 vials
- Official record key
drug-enforcement:D-1278-2014
Official wording
Reason: Presence of Particulate Matter- Confimed customer complaint of particulates embedded in glass container and in contact with product solution.
Code information: Lot 32135DD; Exp 08/15
Distribution pattern: Nationwide
Derived failure modes
-
Foreign material or chemical contamination
Particulate Matter