FDA recall D-0074-2023

Product

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

Reason for recall

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

Distribution

USA Nationwide

Key facts

Status

Terminated

Initiation date

2022-11-14

Report date

2022-12-07

Termination date

2024-08-01

Voluntary/Mandated

Voluntary: Firm initiated

Location

Alpharetta, GA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0074-2023