D-099-2013 Class II Terminated
FDA drug recall D-099-2013 was initiated by Hospira, Inc. on Oct 4, 2012 and is designated Class II. 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 recall status is terminated (terminated May 8, 2014). Affected quantity: 120,350 vials.
Recall Details
- Product Type
- Drugs
- Report Date
- Dec 26, 2012
- Initiation Date
- Oct 4, 2012
- Termination Date
- May 8, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 120,350 vials
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.
Distribution Pattern
Nationwide
Code Information
Lot #: 14-277-DK*, Exp 02/01/14; * may be followed by 01
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-099-2013
- openFDA file date
- Oct 27, 2026
- Loaded by RegDataLab
- Oct 29, 2026