NDC 63323-492

Xylocaine MPF 10 mg per 1 mL injection, solution

Where it's made

Factory	Where	Role	Last FDA inspection
Fresenius Kabi Austria	Austria 8055, Austria	Makes it, tests it and packages it	Problems found, fixed voluntarilyMar 21, 2024 · 9 inspections
Fresenius Kabi USA, LLC	Grand Island, NY, United States	Makes it and tests it	Problems found, fixed voluntarilyOct 13, 2023 · 14 inspections, 2 with FDA action
Fresenius Kabi USA, LLC	Melrose Park, IL, United States	Makes it and tests it	Problems found, fixed voluntarilyAug 24, 2023 · 13 inspections, 2 with FDA action
HP Halden Pharma AS	Halden, Norway	Makes it, tests it and packages it	Problems found, fixed voluntarilyMay 10, 2023 · 7 inspections

Jul 16, 2026 · Class II · Fresenius Kabi USA, LLC
Presence of Particulate Matter: Hair was found in products
Lots: Lot #: 6130235, Exp. Date 02/2027
Jul 16, 2026 · Class II · Fresenius Kabi USA, LLC
Presence of Particulate Matter: Hair was found in products
Lots: Lot #: 6133986, Exp. Date 02/2029
Apr 13, 2022 · Class II · Mckesson Medical-Surgical Inc. Corporate Office
cGMP deviations: Temperature abuse
Lots: McKesson Medical-Surgical (MMS) is not able to identify the particular lot number received by a particular consignee for the recalled prescription products. Each letter includes the date it was distributed to customers and the dates that impacted product may have been shipped to the customer.
Apr 13, 2022 · Class II · Mckesson Medical-Surgical Inc. Corporate Office
cGMP deviations: Temperature abuse
Lots: McKesson Medical-Surgical (MMS) is not able to identify the particular lot number received by a particular consignee for the recalled prescription products. Each letter includes the date it was distributed to customers and the dates that impacted product may have been shipped to the customer.
Jun 25, 2021 · Class II · Fresenius Kabi USA LLC
Low out of specification results for epinephrine assay.
Lots: Batch, expiry: Batch 6123435, exp 01/2022; 6124730, 6124731, exp 07/2022

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: NDA NDA006488
On the market since: Aug 12, 2010
Package NDCs: 63323-492-16 63323-492-26 63323-492-36 63323-492-41 63323-492-43 63323-492-45
Official label: DailyMed (National Library of Medicine), updated Apr 22, 2025

Got it by mail or from a pharmacy you don't know? Look the pharmacy up on Who Filled My Rx?