D-0462-2020 Class II
FDA drug recall D-0462-2020 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: 81969 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
- 81969 units
Product Description
Natural Ophthalmics Ortho-K Thick Comfort Gel, 15 mL, NDC 68770-143-15
Reason for Recall
Lack of Assurance of Sterility
Distribution Pattern
U.S.A. Nationwide
Code Information
17210 7/19 17378 12/19 18175 7/20