D-0442-2020 Class II

Recalled by Altaire Pharmaceuticals, Inc. — Aquebogue, NY

Recall Details

Product Type
Drugs
Report Date
November 27, 2019
Initiation Date
July 2, 2019
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
75996 units

Product Description

OCuSOFT Goniosoft Hypromellose 2.5% Ophthalmic Demulcent Solution, Net Wt. 0.5 fl oz (15 mL), Mfd. for: OCuSOFT Inc. PO Box 429 Richmond, TX 77406-0429, NDC 54799-503-15

Reason for Recall

Lack of Assurance of Sterility

Distribution Pattern

U.S.A. Nationwide

Code Information

17303 10/20 18032 2/21 18235 9/21 18285 11/21 19021 1/22 16260 9/19