Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Subpotent drug: Out of specification for assay at the end-of-shelf-life 24-month period.
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
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Reason Chemical contamination; presence of lead and lithium above specification
Reason Failed dissolution specifications: Stability testing found that the lot did not meet dissolution specifications.
Reason Lack of Assurance of Sterility
Reason Failed dissolution specifications: this product is being recalled due to this batch not meeting dissolution specifications.
Reason Subpotent drug
Tell us which medications you take. If the FDA recalls one, we email you - in plain English, with what to do. Free.