FDASeptember 1, 2021drug

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

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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

What to do

FDA enforcement status: Terminated

Brands named

monarch pcmmonarch

UPCs

342808103065342808103126

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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