Key Takeaway

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, N by Acella Pharmaceuticals, LLC was recalled on November 14, 2022. The hazard: Subpotent drug: Out of specification for assay at the end-of-shelf-life 24-month period.

FDA Drug Class III Terminated

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, N

Recalled: November 14, 2022 ~528 cartons units affected D-0074-2023

Description

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

Hazard / Reason

Subpotent drug: Out of specification for assay at the end-of-shelf-life 24-month period.

Class III: Product that is not likely to cause adverse health consequences.

Class III is the least severe classification. The product is unlikely to cause adverse health consequences but still violates FDA regulations.

Products Affected

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, N

Drugs

Company Information

Acella Pharmaceuticals, LLC

Alpharetta, GA, United States

View all 15 recalls by Acella Pharmaceuticals, LLC →

Distribution

USA Nationwide

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Frequently Asked Questions

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What remedy is available for this recall?

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Where can I find the original recall notice?

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