FDA Recall D-1234-2014
Hospira, Inc. · Lake Forest, IL
Class I — life-threatening Terminated 414 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, 10 mg/mL, NDC 0409-4276-01, Hospira, Inc., Lake Forest, IL 60045.
Reason for recall
Presence of Particulate Matter: Oxidized stainless steel found in vial of 1% Lidocaine Hydrochloride Injection, USP.
Recall record
- Recall number
D-1234-2014- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- Nationwide
- Recall initiated
- 2013-09-16
- Classified by FDA Center
- 2014-04-14
- FDA published
- 2014-04-23
- Terminated
- 2014-11-04
- 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