Drug product
Refresh Tears (Carboxymethylcellulose Sodium Solution) 0.5%, Lubricant Eye Drops, Sterile packaged as 1) two 15 mL bottles, USPC Code 784190442214, 2) 4x15 mL and one 5 mL bonus bottles, USPC Code 069886941746, Distributed by Cell Distributors, Union, NJ
D-0865-2017
Product summary
- Event
- Event 76861
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2,634 bottles (58 bottles/5mL & 2576 bottles/15 mL)
- Official record key
drug-enforcement:D-0865-2017
Official wording
Reason: Labeling: Not elsewhere classified; product labeling lacks a NDC number, net weight information and does not contain the Drug Facts Panel.
Code information: all lots Expiration date August 2019
Distribution pattern: Nationwide
Derived failure modes
-
Unknown
Labeling: Not elsewhere classified; product labeling lacks a NDC number, net weight information and does not contain the Drug Facts Panel.