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.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class III recall involving subpotency with no reported illnesses or injuries stated in the source text. Subpotency of an active ingredient or preservative in a topical drug represents a quality defect, but without evidence of harm or risk of serious injury, it falls under Moderate severity per the rubric criteria for minor quality issues without reported adverse events.
Plain-English summary
Monarch PCM, LLC is recalling Hydroquinone, USP, 4% Skin Bleaching Cream packaged in 1 oz tubes. The recall affects Lot 21FP1731 with expiration date 05/2023, NDC 69367-174-01. The product was manufactured for Westminster Pharmaceuticals, LLC.
The recall was initiated due to subpotency issues. One product tested below specification for active ingredient assay, and another tested below specification for preservative assay. This means the medication may not contain the expected amount of active ingredient or preservative needed for safety and efficacy.
Approximately 6,305 tubes were distributed in Ohio and Tennessee. The product is prescription-only (Rx only). Consumers who have this product should contact their pharmacist or healthcare provider for guidance. Patients should not stop taking their medication without consulting their doctor.
The recalled product
- Product
- HYDROQUINONE (HYDROQUINONE)
- Brand
- HYDROQUINONE
- Manufacturer
- Monarch PCM, LLC
- Category
- Drug — Topical Prescription
- Affected units
- 6,305
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot: 21FP1731 Exp 05/2023
UPCs (1)
- 369367174015
Distribution
Part of a larger recall action
This product is one of 2 recalled by Monarch PCM, LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
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