D-0428-2020 Class II
FDA drug recall D-0428-2020 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: 2,392 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
- 2,392 units
Product Description
iSolutions Nano Tears MO Clear Emollient Lubricant Drops Intensive Sterile, 10 mL, Manufactured by Altaire Pharmaceuticals, Inc. Aquebogue, NY 11931, NDC 59390- 145-10
Reason for Recall
Lack of Assurance of Sterility
Distribution Pattern
U.S.A. Nationwide
Code Information
18052 2/20