FDA recall D-1427-2015

Product

Surgicept (Ethyl alcohol 70% w/w) WATERLESS Surgical Hand Scrub & Healthcare Personnel Handwash in 1150 mL bottles. MARKETED BY: CafeFusion, Leawood, KS 66211, MANUFACTURED FOR: HEALTHPOINT, LTD Ft. Worth, Texas 76107, MANUFACTURED BY: DPT LABORATORIES, LTD 3300 Research Plaza Brooks City-Base, Texas 78235. NDC: 0064-1080-11

Reason for recall

Chemical Contamination: Naphthalene compound identified in the product after complaints of a petroleum odor.

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2015-09-04

Report date

2015-09-16

Termination date

2016-11-17

Voluntary/Mandated

Voluntary: Firm initiated

Location

Fort Worth, TX, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1427-2015