Acella Pharmaceuticals, LLC: Drug Recall

Recall #D-0074-2023 · 11/14/2022

Class III: Low Risk

Recall Details

Recall Number: D-0074-2023
Classification: Class III
Product Type: Drug
Recalling Firm: Acella Pharmaceuticals, LLC
Status: Terminated
Date Initiated: 11/14/2022
Location: Alpharetta, GA, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 528 cartons

Reason for Recall

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

Product 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

Distribution Pattern

USA Nationwide

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 04/24/2024

Subpotent drug
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.