Acella Recalls Sodium Sulfacetamide Cleansing Pads for Subpotency
Acella Pharmaceuticals is recalling Sodium Sulfacetamide 10% Sulfur 4% Cleansing Pads because testing found the drug out of specification for potency at shelf-life expiration. 528 cartons distributed nationwide are affected.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class III recall for a manufacturing specification failure. No illnesses or injuries have been reported. Class III recalls are defined by the FDA as situations unlikely to cause adverse health consequences; the theoretical hazard of reduced drug efficacy is present but no actual harm has been documented.
Plain-English summary
Acella Pharmaceuticals, LLC is recalling Sodium Sulfacetamide 10% Sulfur 4% Cleansing Pads (NDC 42192-113-60) in 60-pad cartons. The product failed to meet its assay specification for drug potency when tested at the end of the 24-month shelf-life period.
Affected lots are 21084 and 21085 with expiration date June 30, 2023. A total of 528 cartons were distributed throughout the United States.
Consumers and healthcare providers who have the affected product should discontinue use and contact Acella Pharmaceuticals or consult their healthcare provider regarding replacement product or alternative treatment options.
The recalled product
- Product
- Sodium Sulfacetamide 10% Sulfur 4% Cleansing Pads, Net weight 3.7g (60 cleansing pads Net weight 3.7 g each per carton,) Rx Only, Manufactured For: Acella Pharmaceuticals, LLC Alpharetta, GA 300025, NDC 42192-113-60
- Manufacturer
- Acella Pharmaceuticals, LLC
- Category
- Drug
- Hazard
- Affected units
- 528
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Lot#: 21084
- 21085
- Exp 06/30/2023
Distribution
Distributed nationwide across the United States.
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