Drug recall D-0497-2017

Class II Terminated reported Mar 8, 2017

Product

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

Reason for recall

Lack of assurance of sterility

Lots and codes

Lot # G15908, Exp 10/2018; G15909, Exp 01/2018; G16904, Exp 01/2019; G16908, Exp 02/2019; G16912, G16913, Exp 03/2019

Recall details

Recalling firm
United Exchange Corporation, Cerritos, CA
Quantity
112,320 bottles
Distribution
Nationwide, Puerto Rico and Guyana
Type
Voluntary: Firm initiated
Recall initiated
September 2, 2016
Terminated
June 19, 2017