Lidocaine HCl Injection, USP, 1% (10 mg/mL), 30 mL Single-dose Teartop Vial, packaged in 25-count...
FDA Recall #D-099-2013 — Class II — October 4, 2012
Product Description
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.
Reason for Recall
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.
Recalling Firm
Hospira, Inc. — Lake Forest, IL
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
120,350 vials
Distribution
Nationwide
Code Information
Lot #: 14-277-DK*, Exp 02/01/14; * may be followed by 01
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated