US Pharmaceuticals Recalls Cool Hot Ice Analgesic Gel Due to Water Quality Issues
US Pharmaceuticals is recalling 246 cases of Cool Hot Ice Analgesic 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 situation where use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences. The source text does not report any illnesses or injuries, and the hazard is related to manufacturing process deviations rather than a confirmed high-risk pathogen or structural defect.
Plain-English summary
US Pharmaceuticals Inc. is recalling 246 cases of Cool Hot Ice Analgesic Gel, 8 oz (227 g). The product is distributed by Unipack Inc. in Pittsburg, PA, and was distributed nationwide in the USA. The specific lot number is 14L18, with an expiration date of 09/2020.
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.
Consumers who have this product should stop using it and contact the recalling firm or their point of purchase for instructions on return or disposal.
The recalled product
- Product
- Cool Hot Ice Analgesic Gel, 8 oz (227 g) Distributed by: Unipack Inc. Pittsburg, PA 15239, USA. UPC 7 51393 00608 6
- Manufacturer
- US Pharmaceuticals Inc.
- Category
- Drug — Topical Analgesic
- Affected units
- 246
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)
- Lot # 14L18
- EXP 09/2020
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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