FDA recall D-1056-2014

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.

Reason for recall

Marketed without an Approved NDA/ANDA.

Distribution

Nationwide and Puerto Rico

Key facts

Status

Terminated

Initiation date

2013-04-24

Report date

2014-02-12

Termination date

2017-05-02

Voluntary/Mandated

Voluntary: Firm initiated

Location

Stuart, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1056-2014