D-0452-2020 Class II
FDA drug recall D-0452-2020 was initiated by Altaire Pharmaceuticals, Inc. on July 2, 2019 and is designated Class II. Reason for recall: Lack of Assurance of Sterility Affected quantity: 19632 units.
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
- 19632 units
Product Description
OCuSOFT retaine NaCl Sodium Chloride Hypertonicity Opthalmic Ointment, Net. wt. 1/8 oz (3.5 g), Sterile, Distributed by OCuSOFT, Inc. Rosenberg, TX 77471 USA
Reason for Recall
Lack of Assurance of Sterility
Distribution Pattern
U.S.A. Nationwide
Code Information
Lot #: SAP 1/20 SFI 6/20 TCI 3/21