Open Nature Cough Drops Menthol-Cough Suppressant/Oral Anesthetic Peppermint Naturally Flavored, packaged in Bags of 30
Summary
The FDA issued a Class III for Open Nature Cough Drops Menthol-Cough Suppressant/Oral Anesthetic Peppermint Nat by Bestco LLC. Reason: Subpotent drug: Low OOS for menthol content at the three month room temperature..
Details
Source
Drug Recall
External ID
D-0879-2022
Action Date
2022-05-25
Status
Terminated
Category
drug
Product Description
Open Nature Cough Drops Menthol-Cough Suppressant/Oral Anesthetic Peppermint Naturally Flavored, packaged in Bags of 30 lozenges, Distributed By Lucerne Foods, Inc. P.O. Box 99, Pleasanton, CA 96566-0009, UPC 0 79893 41266 5
Lot/Code Info: Lot #: 100010885, Exp 11/2024
Quantity Affected: 2038 bags
Reason for Recall
Subpotent drug: Low OOS for menthol content at the three month room temperature.
Distribution
CA, ID, PA, OK
Type: Voluntary: Firm initiated
Recall Initiated: 2022-04-27
Company
Mooresville, NC
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 44 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Bestco LLC has 6 FDA actions in our database, including 6 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 (Bestco LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Bestco LLC have FDA actions?
Bestco LLC has 6 FDA actions in our database, including 6 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0879-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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