Why it was recalled
Marketed without an Approved NDA/ANDA.
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.
Lot numbers, UPCs & expiration codes
Product Number (s): 60010, 40201, 40202, 40203, 40204, 40205, 40206.
Where it was sold
Nationwide and Puerto Rico
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1056-2014
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Apr 24, 2013
- FDA report date
- Feb 12, 2014
- Quantity
- 316,464 kits
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Insight Instruments, Inc.
Original FDA data
Every field from FDA enforcement report D-1056-2014, exactly as published.
Show all FDA fields
- City
- Stuart
- State
- FL
- Status
- Terminated
- Country
- United States
- Event ID
- 65107
- Address
- 2580 Se Willoughby Blvd
- Code information
- Product Number (s): 60010, 40201, 40202, 40203, 40204, 40205, 40206.
- Postal code
- 34994-4701
- Report date
- Feb 12, 2014
- Product type
- Drugs
- Recall number
- D-1056-2014
- Classification
- Class II
- Recalling firm
- Insight Instruments, Inc.
- Product quantity
- 316,464 kits
- Termination date
- May 2, 2017
- Reason for recall
- Marketed without an Approved NDA/ANDA.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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.
- Distribution pattern
- Nationwide and Puerto Rico
- Recall initiation date
- Apr 24, 2013
- Initial firm notification
- Letter
- Center classification date
- Jan 31, 2014