Sensorcaine (Bupivacaine HCl and Epinephrine Injection, USP) with Epinephrine 1:200,000 (as bitartrate), 0.25%, 125 mg p
Summary
The FDA issued a Class II for Sensorcaine (Bupivacaine HCl and Epinephrine Injection, USP) with Epinephrine 1: by Fresenius Kabi USA, LLC. Reason: Subpotent Drug: Testing results below the defined limit for the epinephrine portion of this product..
Details
Source
Drug Recall
External ID
D-0127-2023
Action Date
2023-01-25
Status
Terminated
Category
drug
Product Description
Sensorcaine (Bupivacaine HCl and Epinephrine Injection, USP) with Epinephrine 1:200,000 (as bitartrate), 0.25%, 125 mg per 50 mL (2.5 mg per mL), 50 mL Multiple Dose Vial (NDC 63323-461-01), packaged in 25 Multiple Dose Vials per tray (NDC 63323-461-57), Rx only, Fresenius Kabi, Lake Zurich, IL 60047.
Lot/Code Info: Batch #: 6128061, exp 03/2024; 6128663, 6128664, exp 05/2024
Quantity Affected: 40,375 vials
Reason for Recall
Subpotent Drug: Testing results below the defined limit for the epinephrine portion of this product.
Distribution
Nationwide in the USA
Type: Voluntary: Firm initiated
Recall Initiated: 2022-11-22
Company
Lake Zurich, 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 83 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-0127-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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