Drug product
1% Lidocaine HCl Injection, USP, 10 mg/mL, 30 mL Vial, Single-dose Preservative Free, Rx only, Hospira, Inc., Lake Forest, IL 60045, USA, NDC 0409-4279-02
D-1815-2015
Product summary
- Firm
- Hospira, Inc.
- Event
- Event 72072
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 100,200 Vials
- Official record key
drug-enforcement:D-1815-2015
Official wording
Reason: Presence of Particulate Matter: particulate matter identified as iron oxide, was found embedded in the neck of glass vials.
Code information: Lot #: 44-359-DK, Exp 08/01/2016
Distribution pattern: Nationwide
Derived failure modes
-
Foreign material or chemical contamination
Particulate Matter