D-1056-2014 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- February 12, 2014
- Initiation Date
- April 24, 2013
- Termination Date
- May 2, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 316,464 kits
Product Description
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.
Reason for Recall
Marketed without an Approved NDA/ANDA.
Distribution Pattern
Nationwide and Puerto Rico
Code Information
Product Number (s): 60010, 40201, 40202, 40203, 40204, 40205, 40206.