D-0447-2020 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
55,134 units

Product Description

OCuSOFT Eye Wash Sterile Isotonic Buffered Solution, 1 FL OZ (30 mL), Manufactured for OCuSOFT, Inc. Richmond, TX 77406-0429, NDC 54799-565-01

Reason for Recall

Lack of Assurance of Sterility

Distribution Pattern

U.S.A. Nationwide

Code Information

18026 1/21 18100 4/21 19052 2/22 19130 5/22