US Pharmaceuticals Recalls CRYO-273 Cold Pain Gel Due to Water Quality Issues
US Pharmaceuticals is recalling CRYO-273 Cold Pain Relieving 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 that may cause temporary or medically reversible health consequences. The hazard is a manufacturing deviation (water quality) without reported illnesses, fitting the Moderate category for low-risk contamination or voluntary precautionary recalls.
Plain-English summary
US Pharmaceuticals Inc. is recalling 314 cases of CRYO-273 Cold Pain Relieving Gel, 128 FL. OZ. The product was distributed nationwide in the USA by CRYO-273.com in Tampa, FL. The recall involves specific lots with expiration dates ranging from August 2019 to June 2020.
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. These quality control failures indicate that the water used to make the gel did not meet required safety and purity standards.
Consumers who have purchased this product should check their lot numbers and expiration dates against the recalled list. If the product matches the recalled lots, consumers 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 128 FL. OZ. Distributed By: CRYO-273.com Tampa, FL 33629. UPC 8 15290 01550 2
- Manufacturer
- US Pharmaceuticals Inc.
- Category
- Drug — Topical Analgesic
- Affected units
- 314
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 #'s 13K17 EXP 08/2019
- 03L17 EXP 09/2019
- 74H18 EXP 06/2020
- 18J18 EXP 06/2020
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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