D-0444-2020 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
- 103856 units
Product Description
OCuSOFT Tetravisc Forte Tetracaine HCl 0.5 % Sterile Anesthetic, Rx only, 5 mL, Mfd. For OCuSOFT, Inc. Rosenberg, TX 77471 Mfg. By: Altaire Pharmaceuticals, Inc., Aquebogue, NY 11931, NDC 54799-504-05
Reason for Recall
Lack of Assurance of Sterility
Distribution Pattern
U.S.A. Nationwide
Code Information
Lot #: 17198, Exp 7/19; 17199, Exp 7/19; 17233, Exp 8/19; 17337, Exp 11/19; 17338, Exp 11/19; 18248, Exp 10/20