US Pharmaceuticals Recalls CRYO-273 Cold Pain Gel Due to Water Quality Issues
US Pharmaceuticals is recalling CRYO-273 Cold Pain Relieving Gel Roll-On 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 that may cause temporary or medically reversible health issues. The hazard is a manufacturing deviation (water quality) without reported illnesses, fitting the Moderate category for low-risk contamination or voluntary precautionary measures.
Plain-English summary
US Pharmaceuticals Inc. is recalling 167 cases of CRYO-273 Cold Pain Relieving Gel Roll-On, 3 FL. OZ. (89 mL). The product is distributed nationwide in the USA by CRYO-273.com in Tampa, FL. The specific lots affected are 09K17 and 13K17, both with an expiration date of 08/2019. The product carries UPC 8 15290 01529 6.
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. Specifically, the purified water utilized in the manufacturing process produced out-of-specification results for either total microbial count or total organic carbon. This indicates that the water used to make the gel did not meet the required quality standards.
Consumers who have purchased this product should check their lot numbers and expiration dates. If the product matches the recalled lots, they should stop using it and contact the distributor or manufacturer for instructions on return or disposal.
The recalled product
- Product
- CRYO-273 Cold Pain Relieving Gel Roll-On 3 FL. OZ. (89 mL) Distributed By: CRYO-273.com Tampa, FL 33629. UPC 8 15290 01529 6
- Manufacturer
- US Pharmaceuticals Inc.
- Category
- Drug — Topical Analgesic
- Affected units
- 167
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 #'s 09K17
- 13K17 EXP 08/2019
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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