FDA-Drug2019-11-27Class II

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

Altaire Pharmaceuticals, Inc.
Hazard

Lack of Assurance of Sterility

Sold states
U.S.A. Nationwide
Affected count
90072 units
Manufactured in
311 W Ln, PO Box 849, Aquebogue, NY, United States
Products
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

Official notice

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

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