Class III โ€” Low Risk

Low risk โ€” use of or exposure to this product is not likely to cause adverse health consequences.

Sodium Sulfacetamide Recalled by Monarch PCM, LLC Due to Subpotency: one product for active ingredient assay and...

Date: September 1, 2021
Company: Monarch PCM, LLC
Status: Terminated
Source: FDA (Drug)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Monarch PCM, LLC directly.

Affected Products

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

Quantity: a) 3305 bottles; b) 840 bottles

Why Was This Recalled?

Subpotency: one product for active ingredient assay and another one for preservative assay

Where Was This Sold?

This product was distributed to 2 states: OH, TN

Affected (2 states)Not affected

About Monarch PCM, LLC

Monarch PCM, LLC has 5 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report