Recalls / Class I
Class ID-0627-2021
Class I— FDA's most serious classification, issued when there is a reasonable probability that use of or exposure to the drug will cause serious adverse health consequences 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.
- Brand name
- Lidocaine Hydrochloride
- Generic name
- Lidocaine Hydrochloride
- Active ingredient
- Lidocaine Hydrochloride
- Route
- Infiltration, Perineural
- NDCs
- 0409-4275, 0409-4713, 0409-4278, 0409-4279, 0409-4776, 0409-4282, 0409-4277, 0409-4276
- FDA application
- ANDA088325
- Affected lot / code info
- Lot EG8933, Exp. 08/01/2022
Why it was recalled
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
Recalling firm
- Firm
- PFIZER, INC
- Manufacturer
- Hospira, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 275 N Field Dr Bldg H3-3N, Lake Forest, Illinois 60045-2579
Distribution
- Quantity
- 139,050 vials
- Distribution pattern
- Nationwide in the USA, Puerto Rico, and Guam
Timeline
- Recall initiated
- 2021-05-03
- FDA classified
- 2021-06-10
- Posted by FDA
- 2021-06-09
- Terminated
- 2023-04-04
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0627-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.