Drug product
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
D-0373-2020
Product summary
- Event
- Event 83265
- Status
- Completed
- Classification
- Class II
- Quantity
- 152,369 units
- Official record key
drug-enforcement:D-0373-2020
Official wording
Reason: Lack of Assurance of Sterility
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
Distribution pattern: U.S.A. Nationwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility