FDA recall D-0951-2017

Phillips Co. · Class II · drug

Product

StaphWash+Plus+ Skin Protectant, Zinc acetate (.1% by volume), 0.3 fl. oz. (3 mL) bottle, Phillips Company, Millerton, OK -- NDC 43074-101-01

Reason for recall

GMP Deviations; FDA inspection found significant manufacturing practices that call into question the safety, identity, strength, quality and purity of unexpired drug products manufactured by the firm.

Distribution

Nationwide and United Kingdom

Key facts

Status: Terminated
Initiation date: 2017-06-08
Report date: 2017-07-12
Termination date: 2020-07-20
Voluntary/Mandated: Voluntary: Firm initiated
Location: Millerton, OK, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0951-2017