D-0865-2017 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- May 31, 2017
- Initiation Date
- April 3, 2017
- Termination Date
- June 18, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2,634 bottles (58 bottles/5mL & 2576 bottles/15 mL)
Product Description
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
Reason for Recall
Labeling: Not elsewhere classified; product labeling lacks a NDC number, net weight information and does not contain the Drug Facts Panel.
Distribution Pattern
Nationwide
Code Information
all lots Expiration date August 2019