FDA Recall D-0627-2021
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
1% Lidocaine HCl Injection, USP, 300 mg/30 mL (10 mg/mL), 30 mL Single-dose vial (NDC 0409-4279-16), packaged in 25 vials per tray (NDC 0409-4279-02), 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-0627-2021- 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)
- 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