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1% Lidocaine HCl Injection, USP, 300 mg/30 mL (10 mg/mL), 30 mL Single-dose vial (NDC 0409-4279-1...

FDA Recall #D-0627-2021 — Class I — May 3, 2021

Recall #D-0627-2021 Date: May 3, 2021 Classification: Class I Status: Terminated

Product Description

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

Recalling Firm

PFIZER, INC — Lake Forest, IL

Classification

Class I — Reasonable probability of serious adverse health consequences or death.

Product Type

Drugs

Product Quantity

139,050 vials

Distribution

Nationwide in the USA, Puerto Rico, and Guam

Code Information

Lot EG8933, Exp. 08/01/2022

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medication immediately and contact your pharmacist or doctor. Do not flush medications down the drain. Return the product to the place of purchase for a refund or replacement.

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