Drug product

Mushatt's No. 9, PsoriWash Medicated Wash, Salicylic Acid 1.8%, 8 oz. (226 g) tube, Distributed by Mushatts, LLC, P.O. Box 372476, Satellite Beach, FL 32937, UPC 8 58245 00203 3.

D-0072-2019

August 03, 2018

Class II

Product summary

Firm: Product Quest Manufacturing LLC
Event: Event 80750
Status: Terminated
Classification: Class II
Quantity: 1,440 tubes
Official record key: drug-enforcement:D-0072-2019

Official wording

Reason: Microbial Contamination of Non-Sterile Products and Subpotent Drug: failure for microbiological growth exceeding specification and low out of specification assay results for salicylic acid.

Code information: Lot: 161794F

Distribution pattern: Nationwide in the USA

Derived failure modes

Microbial contamination
reason.microbial_contamination · v1.0.0

Microbial Contamination
Potency or specification failure
reason.potency_specification_failure · v1.0.0

Subpotent