April 2024 FDA Recall Sodium Sulfacetamide 10 Sulfur 5 Cleanser by Acella Pharmaceuticals, Llc
D-0490-2024 - Subpotent drug
This Class III drug recall was voluntarily initiated by Acella Pharmaceuticals, Llc on April 24, 2024 for the product Sodium Sulfacetamide 10 Sulfur 5 Cleanser. The FDA reported the reason for recall as subpotent drug. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-0490-2024
Subpotent drug
04-24-2024
05-15-2024
7104 Bottles
Recall Profile & Regulatory Data
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Acella Pharmaceuticals, LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide in the US and Puerto Rico.
12-22-2025
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
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
Batch or Lot Expiration Information
Lot# 22085 Exp. date 08/02/2024
