Drug product
Lidocaine HCl Injection, USP, 2%, 20 mg per mL, Preservative-Free, 5 mL Single-Dose Vial, Rx only, For Infiltration and Nerve Block including Epidural and Caudal, Manufactured by: Hospira, Inc., Lake Forest, IL, 60045, NDC 0409-2066-05
D-0020-2015
Product summary
- Firm
- Hospira Inc.
- Event
- Event 68901
- Status
- Terminated
- Classification
- Class I
- Quantity
- 109,110 Vials
- Official record key
drug-enforcement:D-0020-2015
Official wording
Reason: Presence of Particulate Matter: The product was discolored and contained visible particulates (iron oxide) in the solution and embedded in the glass vial.
Code information: Lot Number: 25-550-DD, Exp: 1JAN2015
Distribution pattern: Nationwide
Derived failure modes
-
Foreign material or chemical contamination
Particulate Matter