Class III · Low risk
Sodium Sulfacetamide 10% - Sulfur 5% Cleanser
Subpotent drug
Sodium Sulfacetamide
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Subpotency: one product for active ingredient assay and another one for preservative assay
Cause type: Wrong potency / content
Sub- or super-potent product, or a failed content-uniformity / assay test. You may receive too little or too much active ingredient - a direct dosing risk. All wrong potency / content recalls.
What was recalled
Sodium Sulfacetamide, 10%, Wash, packaged in bottles: a) 6 fl oz (177 mL) NDC 42808-103-06 UPC 3 42808 10306 5; b) 12 fl oz (354.8 mL) NDC 42808-103-12 UPC 3 42808 10312 6, Rx only, Manufactured in the U.S.A. for Exact-Rx, Inc., Melville, NY 11747
Affected NDCs
42808-0103-06
42808-0103-12
Compare with the code on your package — it is the most precise check available.
Drug: Sulfacetamide
- Recalling firm
- Monarch PCM, LLC
- NDC code
- 42808-103-06
- Origin
- TX, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0817-2021 · FDA notice
Low risk, still worth a check. Class III means the product is unlikely to cause harm but breaks an FDA rule (often labeling). If your lot matches, your pharmacy will normally swap it; there is no need for alarm. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Sulfacetamide recalls
See all
Class III · Low risk
Sodium Sulfacetamide 10% Sulfur 4% Cleansing Pads
Subpotent drug: Out of specification for assay at the end-of-shelf-life 24-month period.
Class II · Moderate risk
CSF-HC Otic Insufflation Capsule
CGMP Deviations
Class II · Moderate risk
CSF Otic Insufflation Capsule
CGMP Deviations
Class II · Moderate risk
Sodium Sulfacetamide 9.8% & Sulfur 4.8% Cleanser
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Other recalls by Monarch PCM, LLC
All 2021 recalls
Class III · Low risk
Phenobarbital Elixir
Does Not Meet USP or OTC Monograph: Product exceeds USP specification for alcohol content
Class II · Moderate risk
Hydroquinone USP
Finished product specification did not meet USP specifications.
Class III · Low risk
Hydroquinone
Subpotency: one product for active ingredient assay and another one for preservative assay
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