D-0391-2015 Class I Terminated
FDA drug recall D-0391-2015 was initiated by Hospira Inc. on Oct 16, 2014 and is designated Class I. Reason for recall: Presence of particulate matter: A returned customer sample was evaluated and found to have human hair attached to a pinched area of the stopper. The recall status is terminated (terminated Dec 29, 2015). Affected quantity: 100,100 units.
Recall Details
- Product Type
- Drugs
- Report Date
- Feb 25, 2015
- Initiation Date
- Oct 16, 2014
- Termination Date
- Dec 29, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 100,100 units
Product Description
1% LIDOCAINE HCl Injection, USP, 10 mg/mL, 30 mL Single-dose, Preservative-Free glass vial (Twenty-five (25) units per box/fifty (50) units per case, NDC 0409-4279-02, Hospira, Inc., Lake Forest, IL 60045
Reason for Recall
Presence of particulate matter: A returned customer sample was evaluated and found to have human hair attached to a pinched area of the stopper.
Distribution Pattern
Nationwide
Code Information
Lot# 40-316-DK, Exp 01APR2016
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0391-2015
- openFDA file date
- Oct 27, 2026
- Loaded by RegDataLab
- Oct 29, 2026