Drug product
1% LIDOCAINE HCl Injection, USP, Preservative-Free, 10 mg/mL, 30 mL Single-dose vials, packaged in 25-count cartons, Rx only, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-4279-02.
D-0382-2015
Product summary
- Firm
- Hospira Inc.
- Event
- Event 69327
- Status
- Terminated
- Classification
- Class I
- Quantity
- 120,900 vials
- Official record key
drug-enforcement:D-0382-2015
Official wording
Reason: Presence of Particulate Matter: Confirmed customer complaint that orange and black particulates, identified as iron oxide, were found embedded within the glass vial and floating in solution.
Code information: Lot number: 31-427-DK, Exp 01JUL2015.
Distribution pattern: Nationwide.
Derived failure modes
-
Foreign material or chemical contamination
Particulate Matter