Benzonatate Capsules, USP, 100 mg, 100 Capsules (10 capsules x 10 unit dose cards), Rx only, Distributed by: American He
Summary
The FDA issued a Class III for Benzonatate Capsules, USP, 100 mg, 100 Capsules (10 capsules x 10 unit dose card by Amerisource Health Services LLC. Reason: Superpotent drug: Assay results were slightly above specification at the time zero point..
Details
Source
Drug Recall
External ID
D-0257-2024
Action Date
2024-01-31
Status
Ongoing
Category
drug
Product Description
Benzonatate Capsules, USP, 100 mg, 100 Capsules (10 capsules x 10 unit dose cards), Rx only, Distributed by: American Health Packaging, Columbus, Ohio 43217. Carton NDC 68084-214-01; Individual Dose NDC 68084-214-11
Lot/Code Info: Lot # 1014208, Exp Mar/31/2025
Quantity Affected: 6,344 cartons
Reason for Recall
Superpotent drug: Assay results were slightly above specification at the time zero point.
Distribution
Nationwide in the USA
Type: Voluntary: Firm initiated
Recall Initiated: 2023-12-26
Company
Columbus, OH
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 60 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Amerisource Health Services LLC has 46 FDA actions in our database, including 46 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 (Amerisource Health Services LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Amerisource Health Services LLC have FDA actions?
Amerisource Health Services 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-0257-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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