The Recall Desk
ModerateFDA (Drugs)·D-1737-2019·Announced 2019-08-21

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.

What this means for you

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
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.

See all 18 products in this recall →