Monarch PCM recalls 4% hydroquinone skin bleaching cream (Rx only) due to failing USP specifications. Affected units were manufactured for Westminster Pharmaceuticals in Nashville, TN. No remedy specified in recall notice.
Finished product specification did not meet USP specifications.
Monarch PCM is recalling 4% hydroquinone skin bleaching cream (Rx only) because it didn't meet USP quality standards. This means the product may not be safe or effective as intended, but the recall doesn't include a specific fix or return process.
The product failed to meet USP specifications, which are strict quality standards for medications. This could mean the cream isn't safe or effective for skin bleaching as intended, but the recall doesn't specify what harm it could cause.
People who have the 4% hydroquinone skin bleaching cream (Rx only) with the specific lot numbers and expiration date listed in the recall notice. Those who use prescription skin lightening products are most at risk if they have this product.
Check for the product name 'Hydroquinone USP, 4% Skin Bleaching Cream', Rx only, 1 oz (28.35g) with lot numbers 21FP1743 or 21FP1745 and expiration date 05/2023.
Look for the lot numbers 21FP1743 or 21FP1745 and expiration date 05/2023 on the product label.
The recall notice does not specify any remedy or fix for this product.
Check for the product name 'Hydroquinone USP, 4% Skin Bleaching Cream', Rx only, 1 oz (28.35g) with lot numbers 21FP1743 or 21FP1745 and expiration date 05/2023.
The recall does not specify a stop-use instruction, so you can continue using it if you have it.
We’ve drafted a message you can send Monarch PCM to request your refund or repair — edit it as you like.
Subject: Recall D-0855-2021 — Monarch PCM Monarch PCM Hello, I own a Monarch PCM that is covered by recall D-0855-2021 from Monarch PCM. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
