FDA recall D-0458-2020

Product

Accutome Rx Accu-WASH, 4 FL OZ (118 mL), Manufactured for Accutome Inc 3222 Phoenixville Pike Malvern, PA 19355 USA Mfd. By: Altaire Pharmaceuticals, Inc. Aquebogue, NY 11931, NDC 63448-411-04

Reason for recall

Lack of Assurance of Sterility

Distribution

U.S.A. Nationwide

Key facts

Status

Completed

Initiation date

2019-07-02

Report date

2019-11-27

Voluntary/Mandated

Voluntary: Firm initiated

Location

Aquebogue, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0458-2020