Drug product
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.
D-1049-2018
Product summary
- Event
- Event 80614
- Status
- Terminated
- Classification
- Class II
- Quantity
- 14,400 bottles
- Official record key
drug-enforcement:D-1049-2018
Official wording
Reason: CGMP Deviations
Code information: Lot #: a) 20171215 and 20171016, b) 20171016
Distribution pattern: NY and CA.
Derived failure modes
-
Manufacturing or process control
CGMP Deviations