Xylocaine-MPF with Epinephrine 1:200,000, (Lidocaine HCl and Epinephrine Injection, USP), 1%, 300 mg/30 mL, (10 mg/mL),
Summary
The FDA issued a Class II for Xylocaine-MPF with Epinephrine 1:200,000, (Lidocaine HCl and Epinephrine Injecti by Fresenius Kabi USA LLC. Reason: Low out of specification results for epinephrine assay..
Details
Source
Drug Recall
External ID
D-0651-2021
Action Date
2021-07-14
Status
Terminated
Category
drug
Product Description
Xylocaine-MPF with Epinephrine 1:200,000, (Lidocaine HCl and Epinephrine Injection, USP), 1%, 300 mg/30 mL, (10 mg/mL), 30 mL Single Dose Vial, 25 Vials per Tray, Rx only, Fresenius Kabi USA, LLC, Lake Zurich, IL 60047. Vial NDC 63323-487-07, Tray NDC 63323-487-37
Lot/Code Info: Batch, expiry: Batch 6123435, exp 01/2022; 6124730, 6124731, exp 07/2022
Quantity Affected: 234,800 vials
Reason for Recall
Low out of specification results for epinephrine assay.
Distribution
Distributed Nationwide in the USA
Type: Voluntary: Firm initiated
Recall Initiated: 2021-06-25
Company
Melrose Park, IL
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 20 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Fresenius Kabi USA LLC has 46 FDA actions in our database, including 46 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Fresenius Kabi USA LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Fresenius Kabi USA LLC have FDA actions?
Fresenius Kabi USA LLC has 46 FDA actions in our database, including 46 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0651-2021" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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