PlainRecalls
FDA Drug Moderate Class II Completed

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

Reported: November 27, 2019 Initiated: July 2, 2019 #D-0458-2020

Product Description

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

Details

Units Affected
90072 units
Distribution
U.S.A. Nationwide
Location
Aquebogue, NY

Frequently Asked Questions

What product was recalled?
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. Recalled by Altaire Pharmaceuticals, Inc.. Units affected: 90072 units.
Why was this product recalled?
Lack of Assurance of Sterility
Which agency issued this recall?
This recall was issued by the FDA Drug on November 27, 2019. Severity: Moderate. Recall number: D-0458-2020.