US Pharmaceuticals Recalls Soothe & Cool Protect Moisture Guard Skin Protectant
US Pharmaceuticals is recalling Soothe & Cool Protect Moisture Guard Skin Protectant due to out-of-specification microbial counts 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, which typically indicates a temporary or medically reversible adverse health consequence. The hazard is a GMP deviation involving microbial counts in an excipient, which is a low-risk contamination issue without reported illnesses.
Plain-English summary
US Pharmaceuticals Inc. is recalling 19,752 units of Soothe & Cool Protect Moisture Guard Skin Protectant (petrolatum 59%), 3.5 oz tubes. The product is manufactured in the USA for Medline Industries, Inc. and carries the NDC 53329-303-22.
The recall was initiated due to Good Manufacturing Practice (GMP) deviations, specifically out-of-specification results for Total Aerobic Microbial count in an excipient purified water sample. The affected lots are 50G17 (expiring 5/2019) and 76J17 (expiring 7/2019).
The product was distributed nationwide within the United States. Consumers should check their inventory for these specific lot numbers and expiration dates. If found, the product should be returned to the point of purchase or disposed of according to local regulations.
The recalled product
- Product
- Soothe & Cool Protect Moisture Guard Skin Protectant (petrolatum 59%),3.5 oz tubes, Manufactured in USA for: Medline Industries, Inc., Mundelein, IL 60060 USA NDC 53329-303-22
- Manufacturer
- US Pharmaceuticals Inc.
- Category
- Drug — Topical Ointment
- Affected units
- 19,752
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 (4)
- Lot #: 50G17
- Exp. 5/2019
- 76J17
- Exp. 7/2019
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 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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