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FDAFDA · Food and drugs·Recall number D-0440-2020

OCuSOFT Homatropine Hydrobromide Ophthalmic Solution, 5%, 5 mL, Rx only, Manufactured for Ocusoft, Inc, Rosenberg, TX 77471, Mfd. by Altaire Pharmaceuticals, Inc, Aquebogue, NY 11931 NDC 54799-431-05

Published November 27, 2019 · Recall initiated: July 2, 2019

Status when published: Completed — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.

What's the hazard

Lack of Assurance of Sterility

What to do

Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit

Recall details

Manufacturer
Altaire Pharmaceuticals, Inc.
Distributor
U.S.A. Nationwide
Lot
17186 6/20 17345 11/20 19010 1/22 17041 2/2020 16217 8/19
Risk classification
Class II
Area (FDA)
drug
Country
United States

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