Equate Cherry Cough Drops, Menthol cough suppressant/Oral Anesthetic, a) 30 drops per bag, item number 20000462, b) 160
Summary
The FDA issued a Class II for Equate Cherry Cough Drops, Menthol cough suppressant/Oral Anesthetic, a) 30 drop by Bestco LLC. Reason: CGMP Deviations: Potential Glass and Silicone particulates in product.
Details
Source
Drug Recall
External ID
D-0332-2024
Action Date
2024-02-28
Status
Terminated
Category
drug
Product Description
Equate Cherry Cough Drops, Menthol cough suppressant/Oral Anesthetic, a) 30 drops per bag, item number 20000462, b) 160 drops per bag, item number 20000463, Bestco, 288 Mazeppa Road, Mooresville, NC 28115
Lot/Code Info: a) 100041954, Exp 12/31/2026; b) 100042048, 100042060, Exp 12/31/2026
Quantity Affected: a) 1597 cases/ 12 pack each b) 73 cases/4 pack each
Reason for Recall
CGMP Deviations: Potential Glass and Silicone particulates in product
Distribution
Nationwide in the US
Type: Voluntary: Firm initiated
Recall Initiated: 2024-01-19
Company
Mooresville, NC
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 41 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 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 (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-0332-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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