D-0382-2015 Class I Terminated
FDA drug recall D-0382-2015 was initiated by Hospira Inc. on Apr 18, 2014 and is designated Class I. Reason for recall: Presence of Particulate Matter: Confirmed customer complaint that orange and black particulates, identified as iron oxide, were found embedded within the glass vial and floating in solution. The recall status is terminated (terminated Nov 7, 2017). Affected quantity: 120,900 vials.
Recall Details
- Product Type
- Drugs
- Report Date
- Feb 11, 2015
- Initiation Date
- Apr 18, 2014
- Termination Date
- Nov 7, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 120,900 vials
Product Description
1% LIDOCAINE HCl Injection, USP, Preservative-Free, 10 mg/mL, 30 mL Single-dose vials, packaged in 25-count cartons, Rx only, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-4279-02.
Reason for Recall
Presence of Particulate Matter: Confirmed customer complaint that orange and black particulates, identified as iron oxide, were found embedded within the glass vial and floating in solution.
Distribution Pattern
Nationwide.
Code Information
Lot number: 31-427-DK, Exp 01JUL2015.
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0382-2015
- openFDA file date
- Oct 27, 2026
- Loaded by RegDataLab
- Oct 29, 2026