NDC 0409-4279

Lidocaine Hydrochloride 10 mg per 1 mL injection, solution

Where it's made

Factory	Where	Role	Last FDA inspection
Hospira, Inc.	Rocky Mount, NC, United States	Makes it, tests it, packages it and labels it	No problems foundFeb 7, 2025 · 11 inspections, 3 with FDA action
Pfizer Healthcare India Private Limited	Anakapalli, India	Makes it, tests it, packages it and labels it	Problems found, fixed voluntarilyOct 18, 2022 · 7 inspections, 1 with FDA action

May 3, 2021 · Class I · Pfizer, Inc
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: Lot EG8933, Exp. 08/01/2022
Aug 25, 2015 · Class II · Hospira, Inc.
Presence of Particulate Matter: particulate matter identified as iron oxide, was found embedded in the neck of glass vials.
Lots: Lot #: 44-359-DK, Exp 08/01/2016
Oct 16, 2014 · Class I · Hospira Inc.
Presence of particulate matter: A returned customer sample was evaluated and found to have human hair attached to a pinched area of the stopper.
Lots: Lot# 40-316-DK, Exp 01APR2016
Apr 18, 2014 · Class I · Hospira Inc.
Presence of Particulate Matter: Confirmed customer complaint that orange and black particulates, identified as iron oxide, were found embedded within the glass vial and floating in solution.
Lots: Lot number: 31-427-DK, Exp 01JUL2015.
Oct 4, 2012 · Class II · Hospira, Inc.
Presence of Particulate Matter: Report of a vial containing visible particulate matter embedded in the glass wall which has the potential to dislodge resulting in the presence of particulate matter in the product.
Lots: Lot #: 14-277-DK*, Exp 02/01/14; * may be followed by 01

Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.

Generic drug: Lidocaine: every company that makes it
Form: injection, solution, epidural; infiltration; intracaudal; perineural
Strength: 10 mg per 1 mL
Approval: ANDA ANDA088329
On the market since: Aug 30, 2005
Package NDCs: 0409-4279-02 0409-4279-16
Official label: DailyMed (National Library of Medicine), updated Oct 19, 2026

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