D-0448-2020 Class II
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
- 296,314 units
Product Description
OCuSOFT Eye Wash Sterile Isotonic, 4 FL OZ (118 mL), Manufactured for OCuSOFT, INC Richmond, TX 7406-0429 Mfd. By: Altaire Pharmaceuticals, Inc. Aquebogue, NY 11931 Made in USA, NDC 54799-565-59
Reason for Recall
Lack of Assurance of Sterility
Distribution Pattern
U.S.A. Nationwide
Code Information
16268 10/19 11/07/2016 16301 11/19 12/09/2016 17088 3/20 4/28/2017 17109 4/20 6/14/2017 17318 10/20 11/10/2017 17323 10/20 1/12/2018 18014 1/21 2/21/2018 18045 2/21 3/16/2018 18059 3/21 5/25/2018 18063 3/21 18117 5/21 18134 5/2