D-1815-2015 Class II Ongoing
FDA drug recall D-1815-2015 was initiated by Hospira, Inc. on Aug 25, 2015 and is designated Class II. Reason for recall: Presence of Particulate Matter: particulate matter identified as iron oxide, was found embedded in the neck of glass vials. The recall status is ongoing. Affected quantity: 100,200 Vials.
Recall Details
- Product Type
- Drugs
- Report Date
- Sep 30, 2015
- Initiation Date
- Aug 25, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 100,200 Vials
Product Description
1% Lidocaine HCl Injection, USP, 10 mg/mL, 30 mL Vial, Single-dose Preservative Free, Rx only, Hospira, Inc., Lake Forest, IL 60045, USA, NDC 0409-4279-02
Reason for Recall
Presence of Particulate Matter: particulate matter identified as iron oxide, was found embedded in the neck of glass vials.
Distribution Pattern
Nationwide
Code Information
Lot #: 44-359-DK, Exp 08/01/2016
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-1815-2015
- openFDA file date
- Oct 27, 2026
- Loaded by RegDataLab
- Oct 29, 2026