The Recall Desk

FDA (Drugs) recall action 88598

Monarch PCM, LLC recalled 2 products on 2021-09-29

The FDA (Drugs) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2021-09-29
Critical
0
Units
6,305

Why these products were recalled

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

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–2 of 2

  • ModerateFDA (Drugs)··2021-09-29

    Sodium Sulfacetamide Wash Recalled for Subpotency Issues

    Monarch PCM, LLC is recalling Sodium Sulfacetamide 10% Wash due to subpotency, meaning some bottles contain insufficient active ingredient or preservative levels.

    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
    Category
    Distribution
    2 states
  • ModerateFDA (Drugs)··2021-09-29

    Hydroquinone Skin Bleaching Cream Recalled for Subpotency Issues

    Monarch PCM, LLC is recalling Hydroquinone 4% Skin Bleaching Cream due to subpotency affecting the active ingredient assay and preservative assay in one product each.

    Product
    HYDROQUINONE (HYDROQUINONE)
    Category
    Distribution
    2 states