Drug product
CVS Health Preservative Free Lubricant Eye Drops (Carboxymethylcellulose Sodium 0.5% Glycerin 0.9%) Sensitive Solution, 30 Sterile Single-Use Containers, 0.02 fl. oz. (0.6 mL) each, Item #994883, Distributed by: CVS Pharmacy Inc., One CVS Drive, Woonsocket, RI 02895, UPC 0 50428 39945 3
D-0379-2020
Product summary
- Event
- Event 83265
- Status
- Completed
- Classification
- Class II
- Quantity
- 114,504 units
- Official record key
drug-enforcement:D-0379-2020
Official wording
Reason: Lack of Assurance of Sterility
Code information: Lot #: RGF 07/19 RHN 08/19 RIH 09/19 RJP 10/19 RKN 11/19 SDC 04/20 SFC 06/20 SFJ 06/20 SGI 07/20 SKF 11/20 TAE 01/21
Distribution pattern: U.S.A. Nationwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility