PlainRecalls
FDA Drug Moderate Class II Terminated

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

Reported: August 21, 2019 Initiated: July 11, 2019 #D-1737-2019

Product Description

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

Reason for Recall

CGMP Deviations: Out of Specification results for either total microbial count or total organic carbon in the purified water utilized in the manufacturing process.

Details

Recalling Firm
US Pharmaceuticals Inc.
Units Affected
167 cases
Distribution
Distributed Nationwide in the USA
Location
Belleville, NJ

Frequently Asked Questions

What product was recalled?
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. Recalled by US Pharmaceuticals Inc.. Units affected: 167 cases.
Why was this product recalled?
CGMP Deviations: Out of Specification results for either total microbial count or total organic carbon in the purified water utilized in the manufacturing process.
Which agency issued this recall?
This recall was issued by the FDA Drug on August 21, 2019. Severity: Moderate. Recall number: D-1737-2019.