Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Subpotent drug
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
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 Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil.
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