Drug product
CVS Health Preservative Free Lubricant Eye Drops (Carboxymethy-Cellulose Sodium 0.5%, Sensitive Solution, 70 Sterile Single-Use Containers, 0.02 fl. oz. (0.6 mL) each, Item #457791, NDC 50428 41429 3, Distributed by: CVS Pharmacy Inc., One CVS Drive, Woonsocket, RI 02895
D-0390-2020
Product summary
- Event
- Event 83265
- Status
- Completed
- Classification
- Class II
- Quantity
- 109,020 units
- Official record key
drug-enforcement:D-0390-2020
Official wording
Reason: Lack of Assurance of Sterility
Code information: Lot #: QHF 08/19 QHI 08/19 QLA 12/19 RBA 02/20 RCF 03/20 RCM 03/20 RDJ 04/20 RFA 06/20 RHI 08/20 RJI 10/20 RKG 11/20 RLE 12/20 SAW 01/21 SBF 02/21
Distribution pattern: U.S.A. Nationwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility