FDAClass IINovember 27, 2019

Accutome recall: Sterility Concern

Accutome Rx Accu-WASH, 4 FL OZ (118 mL), Manufactured for Accutome Inc 3222 Phoenixville Pike Malvern, PA 19355 USA Mfd. By: Altaire Pharmaceuticals…

Why was Accutome recalled?

Lack of Assurance of Sterility

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

18095 4/20

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…
Recalling firm
Altaire Pharmaceuticals, Inc.
Quantity
90072 units
Distribution
U.S.A. Nationwide
Recall date
November 27, 2019
Classification
Class II
Status
Completed
Agency
FDA (drug)
Open FDA enforcement record Latest recalls