D-0414-2020 Class II
FDA drug recall D-0414-2020 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: 6,877 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
- 6,877 units
Product Description
iSolutions ActivEyes Nighttime Lubricant Eye Ointment Preservative Free, Sterile, Net Wt: 3.5 g (1.8 oz), Manufactured by: Altaire Pharmaceuticals, Inc. Aquebogue, NY 11931 NDC 59390-190-50
Reason for Recall
Lack of Assurance of Sterility
Distribution Pattern
U.S.A. Nationwide
Code Information
SKG 11/21 12/28/2018 TAQ 01/22 04/23/2019