Monarch PCM, LLC recalls Hydroquinone, USP, 4% Skin Bleaching Cream, packaged in 1 oz (28.35g) tube, Rx only, Manufactured for: Westminster Phar…

Recall date

September 1, 2021

Source

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

Recall number

D-0818-2021

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

Hydroquinone, 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 5