US Pharmaceuticals Recalls CVS Therapeutic Menthol Gel Due to Water Quality Issues
US Pharmaceuticals is recalling CVS Therapeutic Menthol Gel because the purified water used in manufacturing failed quality tests for microbial count or organic carbon.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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: The recall is classified as FDA Class II, which typically involves a reasonable probability that use may cause temporary or medically reversible health consequences. The hazard is a manufacturing deviation (water quality) without reported illnesses, fitting the 'Moderate' criteria for low-risk contamination or voluntary precautionary measures.
Plain-English summary
US Pharmaceuticals Inc. is recalling CVS Therapeutic Menthol Gel, 8 FL OZ (227 g), distributed by CVS Pharmacy, Inc. The recall involves 5,017 cases of the product that were distributed nationwide in the USA. Specific lot numbers and expiration dates are listed in the official recall notice.
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. Specifically, the purified water utilized in the manufacturing process yielded out-of-specification results for either total microbial count or total organic carbon. This indicates that the water did not meet the required quality standards during production.
Consumers who have purchased this product should check their lot numbers and expiration dates against the list provided by the FDA. If the product matches the recalled lots, consumers should stop using it and contact CVS Pharmacy or US Pharmaceuticals for further instructions or a refund.
The recalled product
- Product
- CVS Therapeutic Menthol Gel, 8 FL OZ (227 g) Distributed by: CVS Pharmacy, Inc. One CVS Drive Woonsocket, RI 02895. UPC 0 50428 48136 3
- Manufacturer
- US Pharmaceuticals Inc.
- Category
- Drug — Topical Analgesic
- Affected units
- 5,017
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 (20)
- Lot #'s 28L17
- 31L17
- 36L17
- 40L17
- 44L17 EXP 09/2019
- 05M17
- 09M17
- 12M17
- 13M17
- 23M17 EXP 10/2019
- 69P17
- 72P17 EXP 11/2019
- 42S17
- 46S17 EXP 12/2019
- 85C18
- 86C18 EXP 03/2020
- 31J18
- 43J18
- 55J18
- 58J18
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 18 recalled by US Pharmaceuticals Inc. 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.
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