Drug product
Lidocaine HCl Injection, USP, 1% (10 mg/mL), 30 mL Single-dose Teartop Vial, packaged in 25-count vials per carton, Rx only, Hospira, Inc., Lake Forest, IL 60045; NDC 0409-4279-02.
D-099-2013
Product summary
- Firm
- Hospira, Inc.
- Event
- Event 63913
- Status
- Terminated
- Classification
- Class II
- Quantity
- 120,350 vials
- Official record key
drug-enforcement:D-099-2013
Official wording
Reason: Presence of Particulate Matter: Report of a vial containing visible particulate matter embedded in the glass wall which has the potential to dislodge resulting in the presence of particulate matter in the product.
Code information: Lot #: 14-277-DK*, Exp 02/01/14; * may be followed by 01
Distribution pattern: Nationwide
Derived failure modes
-
Foreign material or chemical contamination
Particulate Matter