FDA Recall D-0382-2015
Hospira Inc. · Lake Forest, IL
Class I — life-threatening Terminated 1299 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
Product
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.
Recall record
- Recall number
D-0382-2015- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Press Release
- Distribution
- Nationwide.
- Recall initiated
- 2014-04-18
- Classified by FDA Center
- 2015-01-30
- FDA published
- 2015-02-11
- Terminated
- 2017-11-07
- Recalling firm
- Hospira Inc.
- Firm location
- Lake Forest, IL
Drug identification
- Brand name(s)
- LIDOCAINE HYDROCHLORIDE
- Generic name(s)
- LIDOCAINE HYDROCHLORIDE
- Manufacturer(s)
- Hospira, Inc.
- NDC(s)
0409-4275, 0409-4713, 0409-4278, 0409-4279, 0409-4776, 0409-4282, 0409-4277, 0409-4276- Route(s)
- INFILTRATION, PERINEURAL