LET Gel (Lidocaine HCL/Epinephrine Bitartrate/Tetracaine HCL 4%/0.18%/0.5% Topical Gel), Single-use Topical Syringe, 3mL
Right Value Drug Stores, LLC dba Carie Boyd's Prescription Shop
Summary
The FDA issued a Class III for LET Gel (Lidocaine HCL/Epinephrine Bitartrate/Tetracaine HCL 4%/0.18%/0.5% Topic by Right Value Drug Stores, LLC dba Carie Boyd's Prescription Shop. Reason: Product Mix-up: Incorrect Product Formulation.
Details
Source
Drug Recall
External ID
D-0140-2024
Action Date
2023-12-13
Status
Terminated
Category
drug
Product Description
LET Gel (Lidocaine HCL/Epinephrine Bitartrate/Tetracaine HCL 4%/0.18%/0.5% Topical Gel), Single-use Topical Syringe, 3mL syringe, 10/pack, Rx only, Carie Boyd Pharmaceuticals, 8400 Esters Blvd, Ste# 190, Irving, TX 75063, NDC73271-1003-1
Lot/Code Info: Lot#: 09202023@7, Exp 03/18/2024
Quantity Affected: 190 syringes
Reason for Recall
Product Mix-up: Incorrect Product Formulation
Distribution
USA Nationwide
Type: Voluntary: Firm initiated
Recall Initiated: 2023-11-09
Company
Context & Analysis
This is a Class III recall. Class III recalls involve products unlikely to cause adverse health consequences, but that violate FDA regulations.
This was one of 46 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Frequently Asked Questions
What is a Class III recall?
A Class III recall involves products that are unlikely to cause adverse health effects but violate FDA labeling or manufacturing regulations.
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 (Right Value Drug Stores, LLC dba Carie Boyd's Prescription Shop) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Right Value Drug Stores, LLC dba Carie Boyd's Prescription Shop have FDA actions?
This is the only FDA action we have on record for Right Value Drug Stores, LLC dba Carie Boyd's Prescription Shop in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0140-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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