Acella Pharmaceuticals, LLC: Drug Recall

Recall #D-0490-2024 · 04/24/2024

Class III: Low Risk

Recall Details

Recall Number: D-0490-2024
Classification: Class III
Product Type: Drug
Recalling Firm: Acella Pharmaceuticals, LLC
Status: Terminated
Date Initiated: 04/24/2024
Location: Alpharetta, GA, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 7104 Bottles

Reason for Recall

Subpotent 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

Distribution Pattern

Nationwide in the US and Puerto Rico.

Other Recalls by Acella Pharmaceuticals, LLC

Class II: Risk 09/29/2025

Failed dissolution specifications: Stability testing found that the lot did not meet dissolution specifications.
Class III: Low Risk 11/14/2022

Subpotent drug: Out of specification for assay at the end-of-shelf-life 24-month period.
Class III: Low Risk 11/14/2022

Labeling: Not elsewhere classified; the product is being recalled because of customer complaints that the primary vial label was missing a barcode.
Class III: Low Risk 11/14/2022

Labeling: Not elsewhere classified; the product is being recalled because of customer complaints that the primary vial label was missing a barcode.
Class I: Dangerous 04/29/2021

Subpotent Drug

View all recalls by Acella Pharmaceuticals, LLC →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.