FDA Recall D-1278-2014
Hospira Inc. · Lake Forest, IL
Class I — life-threatening Terminated 288 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
Product
Lidocaine HCl Injection, USP, 2%, 20 mg per mL, packaged in 5-mL single-dose vials, 10 vials per box, Rx Only, Hospira, Inc., Lake Forest, IL. 60045, NDC 0409-2066-05.
Reason for recall
Presence of Particulate Matter- Confimed customer complaint of particulates embedded in glass container and in contact with product solution.
Recall record
- Recall number
D-1278-2014- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Press Release
- Distribution
- Nationwide
- Recall initiated
- 2013-12-23
- Classified by FDA Center
- 2014-04-27
- FDA published
- 2014-05-07
- Terminated
- 2014-10-07
- 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)
0409-2066- Route(s)
- EPIDURAL, INFILTRATION, INTRACAUDAL, PERINEURAL