Lidocaine Patch 5%, 1 patch (63629-8755-20) packaged in 30-count patches per carton (63629-8755-1), Rx only, each patch
Summary
The FDA issued a Class III for Lidocaine Patch 5%, 1 patch (63629-8755-20) packaged in 30-count patches per car by Bryant Ranch Prepack, Inc.. Reason: Labeling: Typographical error on the upper left-hand side of the box and individual patch label that has the incorrect dosage form stating, each table.
Details
Source
Drug Recall
External ID
D-0556-2023
Action Date
2023-05-10
Status
Ongoing
Category
drug
Product Description
Lidocaine Patch 5%, 1 patch (63629-8755-20) packaged in 30-count patches per carton (63629-8755-1), Rx only, each patch contains: 700 mg (50mg per gram adhesive) in an aqueous base, Manufactured by: Actavis Laboratories UT, Inc., Relabeled by: Bryant Ranch Prepack, Inc. Burbank, CA 91504 USA
Lot/Code Info: Lot: 204603, Exp: 09/30/2024; Lots:208608, 208749, 208445, 209101, 208609, 208295, 209106, 209102, 209212, 208975, 209211, 209706, 209779, 209624, 209839, 209548, Exp: 12/31/2024; Lots: 204604, 204601, 204550, 204599, 204871, 204555, 205616, Exp: 11/30/2024; Lots: 205612, 204832, 205127, 204996, 205615, 205324, 205494, 205611, 206232, Exp: 10/31/2024.
Quantity Affected: 403 boxes
Reason for Recall
Labeling: Typographical error on the upper left-hand side of the box and individual patch label that has the incorrect dosage form stating, each tablet contains instead of each adhesive patch contains.
Distribution
Nationwide in the USA
Type: Voluntary: Firm initiated
Recall Initiated: 2023-04-20
Company
Burbank, CA
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 45 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Bryant Ranch Prepack, Inc. has 8 FDA actions in our database, including 8 recalls.
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 (Bryant Ranch Prepack, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Bryant Ranch Prepack, Inc. have FDA actions?
Bryant Ranch Prepack, Inc. has 8 FDA actions in our database, including 8 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0556-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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