Monarch PCM, LLC recalls Sodium Sulfacetamide, 10%, Wash, packaged in bottles: a) 6 fl oz (177 mL) NDC 42808-103-06 UPC 3 42808 10306 5; b) 12 f…

Recall date

September 1, 2021

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-0817-2021

FDA classification

Class III

Brand / firm

Monarch PCM, LLC

Sold / distributed

OH, TN

Why it was recalled

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

Class III means the product violates regulations but is not likely to cause harm.

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