Why it was recalled
Lack of assurance of sterility
Product description
Eye Irrigating Solution, 4 fl oz (118 mL) bottle, OTC, Distributed by: Rugby Laboratories, 31778 Enterprise Drive, Livonia, MI 48150, Made in Korea, NDC 0536-1083-97
Lot numbers, UPCs & expiration codes
Lot # G15908, Exp 10/2018; G15909, Exp 01/2018; G16904, Exp 01/2019; G16908, Exp 02/2019; G16912, G16913, Exp 03/2019
Where it was sold
Nationwide, Puerto Rico and Guyana
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-0497-2017
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Sep 2, 2016
- FDA report date
- Mar 8, 2017
- Quantity
- 112,320 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- United Exchange Corporation
Original FDA data
Every field from FDA enforcement report D-0497-2017, exactly as published.
Show all FDA fields
- City
- Cerritos
- State
- CA
- Status
- Terminated
- Country
- United States
- Event ID
- 75092
- Address
- 17211 Valley View Ave
- Code information
- Lot # G15908, Exp 10/2018; G15909, Exp 01/2018; G16904, Exp 01/2019; G16908, Exp 02/2019; G16912, G16913, Exp 03/2019
- Postal code
- 90703-2414
- Report date
- Mar 8, 2017
- Product type
- Drugs
- Recall number
- D-0497-2017
- Classification
- Class II
- Recalling firm
- United Exchange Corporation
- Product quantity
- 112,320 bottles
- Termination date
- Jun 19, 2017
- Reason for recall
- Lack of assurance of sterility
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Eye Irrigating Solution, 4 fl oz (118 mL) bottle, OTC, Distributed by: Rugby Laboratories, 31778 Enterprise Drive, Livonia, MI 48150, Made in Korea, NDC 0536-1083-97
- Distribution pattern
- Nationwide, Puerto Rico and Guyana
- Recall initiation date
- Sep 2, 2016
- Initial firm notification
- Telephone
- Center classification date
- Feb 27, 2017