Drug product
Cornea Coat, Hydroxypropylmethylcellulose, 1.5ml Syringe, Rx Only. Manufactured by: Insight Instruments, Inc., 2580 SE Willoughby Blvd., Stuart, FL 34994, USA. Tel: 772-219-9393.
D-1056-2014
Product summary
- Event
- Event 65107
- Status
- Terminated
- Classification
- Class II
- Quantity
- 316,464 kits
- Official record key
drug-enforcement:D-1056-2014
Official wording
Reason: Marketed without an Approved NDA/ANDA.
Code information: Product Number (s): 60010, 40201, 40202, 40203, 40204, 40205, 40206.
Distribution pattern: Nationwide and Puerto Rico
Derived failure modes
-
Unknown
Marketed without an Approved NDA/ANDA.