Drug product

Soothe&Cool Protect Moisture Guard Skin Protectant, 3.5 oz. (99 g), tube, Manufactured for Medline industries, Inc., Mundelein, IL 60060. NDC 53329-303-22

D-1735-2019

July 11, 2019

Class II

Product summary

Firm: US Pharmaceuticals Inc.
Event: Event 83316
Status: Terminated
Classification: Class II
Quantity: 830 tubes
Official record key: drug-enforcement:D-1735-2019

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 #57J17 EXP 07/2019

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