FDA Recall D-0626-2021
PFIZER, INC · Lake Forest, IL
Class I — life-threatening Terminated 701 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
Product
0.5% Bupivacaine Hydrochloride Injection, USP, 150 mg/30 mL (5 mg/mL), 30 mL Single-dose Teartop Vials (NDC 0409-1162-19), packaged in 25 vials per tray (NDC 0409-1162-02), Rx only, Distributed by Hospira, Inc., Lake Forest, IL 60045 USA.
Reason for recall
Labeling: Label Mix-Up: some vials labeled to contain 0.5% Bupivacaine Hydrochloride Injection, USP may contain 1% Lidocaine HCl Injection, USP and some vials labeled to contain 1% Lidocaine HCl Injection, USP may contain 0.5% Bupivacaine Hydrochloride Injection, USP
Recall record
- Recall number
D-0626-2021- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- Nationwide in the USA, Puerto Rico, and Guam
- Recall initiated
- 2021-05-03
- Classified by FDA Center
- 2021-06-10
- FDA published
- 2021-06-09
- Terminated
- 2023-04-04
- Recalling firm
- PFIZER, 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