NDC 0404-9975
Xylocaine 5 mg per 1 mL / 0.005 mg per 1 mL injection, solution
On the label: Henry Schein, Inc.. It's repackaged: Henry Schein, Inc. rebottles it from Fresenius Kabi, LLC's NDC 63323-481.
Where the pills inside were made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| 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 |
Recalls
- 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.
Product details
- Generic drug
- Epinephrine and Lidocaine: every company that makes it
- Form
- injection, solution, infiltration; perineural
- Strength
- 5 mg per 1 mL / 0.005 mg per 1 mL
- Approval
- NDA NDA006488
- On the market since
- Jan 10, 2022
- Package NDCs
0404-9975-50- Official label
- DailyMed (National Library of Medicine), updated Aug 7, 2025
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