D-0471-2020 Class II
FDA drug recall D-0471-2020 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: 1,381,638 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
- 1,381,638 units
Product Description
TRP Pink Eye Relief, 10 mL, NDC 17312-013-15
Reason for Recall
Lack of Assurance of Sterility
Distribution Pattern
U.S.A. Nationwide
Code Information
17185 6/20 17228 7/20 17349 11/20 18073 3/21 18218 8/21 18303 12/21