Recalls / Class III
Class IIID-0490-2024
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
- Brand name
- Sodium Sulfacetamide 10 Sulfur 5 Cleanser
- Generic name
- Sulfacetamide Sodium And Sulfur
- Active ingredients
- Sulfacetamide Sodium, Sulfur
- Route
- Topical
- NDC
- 42192-136
- Affected lot / code info
- Lot # 22085 Exp. date 08/02/2024
Why it was recalled
Subpotent drug
Recalling firm
- Firm
- Acella Pharmaceuticals, LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1880 Mcfarland Pkwy Ste 110, N/A, Alpharetta, Georgia 30005-1795
Distribution
- Quantity
- 7104 Bottles
- Distribution pattern
- Nationwide in the US and Puerto Rico.
Timeline
- Recall initiated
- 2024-04-24
- FDA classified
- 2024-05-08
- Posted by FDA
- 2024-05-15
- Terminated
- 2025-12-22
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0490-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.