FDA Recall D-0218-2017
Hospira Inc., A Pfizer Company · Lake Forest, IL
Class I — life-threatening Ongoing 3570 days on record
Product
Bupivacaine Hydrochloride Inj., USP (2.5 mg/mL) 0.25%, packaged in 30 mL Single-dose Preservative-Free vials, Rx Only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-1159-02
Reason for recall
Presence of particulate matter: Confirmed customer report for the presence of particulate matter within a single vial.
Recall record
- Recall number
D-0218-2017- Classification
- Class I
- Status
- Ongoing
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- Nationwide
- Recall initiated
- 2016-08-04
- Classified by FDA Center
- 2016-12-22
- FDA published
- 2016-12-28
- Recalling firm
- Hospira Inc., A Pfizer Company
- 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
Operational response
A Class I recall indicates a strong likelihood of serious adverse health consequence or death. Pull affected lots from active dispensing immediately. Segregate inventory in a marked, locked location pending destruction or return. If product has already been dispensed, identify affected patients and contact them by your standard recall-notification protocol.
For the official FDA enforcement record, see FDA's Recall Search.