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 fl
Recalled September 29, 2021 · FDA recall D-0817-2021 · Monarch PCM
Hazard
Subpotency: one product for active ingredient assay and another one for preservative assay · FDA Class III
Units
a) 3305 bottles; b) 840 bottles
Sold at
OH, TN
Description
Subpotency: one product for active ingredient assay and another one for preservative assay
Product
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
Manufacturer(s)
Monarch PCM, LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →