D-0373-2020 Class II
FDA drug recall D-0373-2020 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: 152,369 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
- 152,369 units
Product Description
CVS Health Natural Tears Lubricant Eye Drops, Preservative Free Ophthalmic Solution, Sterile, 0.02 Fl. oz., (0.6 mL) each, 32 Single Use Vials, Item #538397, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895
Reason for Recall
Lack of Assurance of Sterility
Distribution Pattern
U.S.A. Nationwide
Code Information
Lot #: SEI 5/21 SGC 7/21 QGB 07/19 QID 09/19 RJC 10/20 RCJ 03/20 RCB 03/20 TCJ 03/22