D-1049-2018 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- August 15, 2018
- Initiation Date
- July 17, 2018
- Termination Date
- September 11, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 14,400 bottles
Product Description
Eyewash Purified water 98.3%, Ophthalmic Solution, packaged in a) 4 FL OZ (NDC 6910-3218-07) and b) 8 Fl OZ (NDC 6910-3218-08) bottles, 77656 Flora Rd, Palm Desert, CA 92211.
Reason for Recall
CGMP Deviations
Distribution Pattern
NY and CA.
Code Information
Lot #: a) 20171215 and 20171016, b) 20171016