Drug recall D-0627-2021

Class I Terminated reported Jun 9, 2021

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

Lots and codes

Lot EG8933, Exp. 08/01/2022

Recall details

Recalling firm
PFIZER, INC, Lake Forest, IL
Quantity
139,050 vials
Distribution
Nationwide in the USA, Puerto Rico, and Guam
Type
Voluntary: Firm initiated
Recall initiated
May 3, 2021
Terminated
April 4, 2023

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