Recall Enforment Report D-0817-2021

Multi event Drug Recall Enforcement Report Class III voluntary initiated by Monarch PCM, LLC, originally initiated on 09-01-2021 for the 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 The product was recalled due to subpotency: one product for active ingredient assay and another one for preservative assay. The product was distributed in Oh, Tn and the recall is currently ongoing.

Recall Enforcement Reports

Recall Number Initiation Date Report Date Recall Classification Quantity Product Description Recall Reason Status
D-0817-202109-01-202109-29-2021Class IIIa) 3305 bottles; b) 840 bottlesSodium 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 11747Subpotency: one product for active ingredient assay and another one for preservative assayOngoing
D-0818-202109-01-202109-29-2021Class III6305 tubesHydroquinone, USP, 4% Skin Bleaching Cream, packaged in 1 oz (28.35g) tube, Rx only, Manufactured for: Westminster Pharmaceuticals, LLC Nashville, TN 37217, NDC 69367-174-01 UPC 3 69367 17401 5Subpotency: one product for active ingredient assay and another one for preservative assayOngoing

Recalled Products

NDC Proprietary Name Non-Proprietary Name Dosage Form Route Name Company Name Product Type
42808-103Exact-rx Sodium Sulfacetamide Wash 10% Sodium SulfacetamideLiquidTopicalExact-rx, Inc.Human Prescription Drug
69367-174Hydroquinone HydroquinoneCreamTopicalWestminster Pharmaceuticals, LlcHuman Prescription Drug