Drug product

CRYO-273 Cold Pain Relieving Gel 128 FL. OZ. Distributed By: CRYO-273.com Tampa, FL 33629. UPC 8 15290 01550 2

D-1741-2019

July 11, 2019

Class II

Product summary

Firm: US Pharmaceuticals Inc.
Event: Event 83316
Status: Terminated
Classification: Class II
Quantity: 314 cases
Official record key: drug-enforcement:D-1741-2019

Official wording

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

Code information: Lot #'s 13K17 EXP 08/2019, 03L17 EXP 09/2019, 74H18 EXP 06/2020, 18J18 EXP 06/2020

Distribution pattern: Distributed Nationwide in the USA

Derived failure modes

Manufacturing or process control
reason.manufacturing_process_control · v1.0.0

CGMP Deviations
Potency or specification failure
reason.potency_specification_failure · v1.0.0

Out of Specification