US Pharmaceuticals Recalls Soothe&Cool Protect Moisture Guard Skin Protectant
US Pharmaceuticals is recalling 830 tubes of Soothe&Cool Protect Moisture Guard Skin Protectant due to out-of-specification results for microbial count or organic carbon in purified water.
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, but the source text does not report any illnesses, injuries, or hospitalizations. The hazard is a manufacturing deviation (CGMP) regarding water quality, which fits the criteria for a moderate severity score involving low-risk contamination or voluntary precautionary measures without reported harm.
Plain-English summary
US Pharmaceuticals Inc. is recalling 830 tubes of Soothe&Cool Protect Moisture Guard Skin Protectant, 3.5 oz. (99 g), tube. The product is manufactured for Medline Industries, Inc., and carries the NDC 53329-303-22. The specific lot affected is #57J17 with an expiration date of 07/2019.
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. The product was distributed nationwide in the USA.
Consumers should check their inventory for the specific lot number and expiration date listed above. If the product matches the recalled lot, consumers should stop using it and contact US Pharmaceuticals Inc. for further instructions or a refund.
The recalled product
- Product
- Soothe&Cool Protect Moisture Guard Skin Protectant, 3.5 oz. (99 g), tube, Manufactured for Medline industries, Inc., Mundelein, IL 60060. NDC 53329-303-22
- Manufacturer
- US Pharmaceuticals Inc.
- Category
- Drug — Topical Skin Protectant
- Affected units
- 830
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 #57J17 EXP 07/2019
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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