Hydroquinone 4% Skin Bleaching Cream Recalled for Specification Failure
Monarch PCM, LLC is recalling Hydroquinone USP 4% Skin Bleaching Cream because the finished product did not meet USP (United States Pharmacopeia) specifications. The recall affects 11,419 tubes distributed in Tennessee.
What this means for you
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 II recall involving a prescription drug with a manufacturing specification failure. The source text does not report any illnesses, injuries, or deaths, and the hazard is a quality-control issue rather than direct contamination or high-risk pathogen. Per the rubric, Class II recalls without reported illness typically score 2 (Moderate).
Plain-English summary
Monarch PCM, LLC is recalling Hydroquinone USP 4% Skin Bleaching Cream (NDC 69367-174-01) manufactured for Westminster Pharmaceuticals, LLC. The finished product failed to meet United States Pharmacopeia (USP) specifications.
The recalled product consists of 11,419 tubes in 1 oz (28.35g) sizes from lot numbers 21FP1743 and 21FP1745 with an expiration date of May 2023. Distribution was limited to Tennessee.
Consumers who have this product should discontinue use and consult their healthcare provider or pharmacist regarding appropriate next steps. Patients should not stop taking prescribed medications without medical guidance. Healthcare providers and patients with questions can contact their pharmacy or the manufacturer.
The recalled product
- Product
- HYDROQUINONE (HYDROQUINONE)
- Brand
- HYDROQUINONE
- Manufacturer
- Monarch PCM, LLC
- Hazard
- quality-specification-failure
- usp-non-compliance
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 (2)
- Lots: 21FP1743
- 21FP1745 Exp. 05/2023
Distribution
Distributed in 1 state:
- TN
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