Sodium Sulfacetamide 10% - Sulfur 5% Cleanser, Rx Only, 6 oz (170.3 g) Bottle, Manufactured for Acela Pharmaceuticals, L
Summary
The FDA issued a Class III for Sodium Sulfacetamide 10% - Sulfur 5% Cleanser, Rx Only, 6 oz (170.3 g) Bottle, M by Acella Pharmaceuticals, LLC. Reason: Subpotent drug.
Details
Source
Drug Recall
External ID
D-0490-2024
Action Date
2024-05-15
Status
Terminated
Category
drug
Product Description
Sodium Sulfacetamide 10% - Sulfur 5% Cleanser, Rx Only, 6 oz (170.3 g) Bottle, Manufactured for Acela Pharmaceuticals, LLC Alphareta, GA 30005, NDC 42192-136-06
Lot/Code Info: Lot # 22085 Exp. date 08/02/2024
Quantity Affected: 7104 Bottles
Reason for Recall
Subpotent drug
Distribution
Nationwide in the US and Puerto Rico.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-04-24
Company
Alpharetta, GA
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 36 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Acella Pharmaceuticals, 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 (Acella Pharmaceuticals, LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Acella Pharmaceuticals, LLC have FDA actions?
Acella Pharmaceuticals, 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-0490-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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