FDA Recall D-1216-2015
Hospira Inc. · Lake Forest, IL
Class I — life-threatening Terminated 278 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
Product
Bupivacaine Hydrochloride Inj., USP, 0.5% (5 mg/mL), Preservative-Free, 30 mL Single Use Vials, Rx only. HOSPIRA, INC., LAKE FOREST, IL 60045 USA. NDC: 0409-1162-02.
Reason for recall
Presence of Particulate Matter: Presence of free-floating and embedded iron oxide particles.
Recall record
- Recall number
D-1216-2015- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Distribution
- U.S. Nationwide including Guam.
- Recall initiated
- 2015-04-23
- Classified by FDA Center
- 2015-07-08
- FDA published
- 2015-07-15
- Terminated
- 2016-01-26
- Recalling firm
- Hospira Inc.
- Firm location
- Lake Forest, IL
Drug identification
- Brand name(s)
- BUPIVACAINE HYDROCHLORIDE
- Generic name(s)
- BUPIVACAINE HYDROCHLORIDE
- Manufacturer(s)
- Hospira, Inc.
- NDC(s)
0409-1159, 0409-1160, 0409-1162, 0409-1163, 0409-1165, 0409-9043, 0409-9046, 0409-9045, 0409-9042- Route(s)
- EPIDURAL, INFILTRATION, INTRACAUDAL, PERINEURAL