Home / Recalls / United Exchange Corporation / D-0497-2017

D-0497-2017 Class II Terminated

Recalled by United Exchange Corporation — Cerritos, CA

Recall Details

Product Type
Drugs
Report Date
March 8, 2017
Initiation Date
September 2, 2016
Termination Date
June 19, 2017
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
112,320 bottles

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

Reason for Recall

Lack of assurance of sterility

Distribution Pattern

Nationwide, Puerto Rico and Guyana

Code Information

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

Other recalls by United Exchange Corporation

  • D-0498-2017 Class II — Eye Wash, 4 fl oz (118 mL) bottle, OTC, Distributed by: United Exchange Corp., (September 2, 2016)
  • D-0499-2017 Class II — EYE WASH, 4 fl oz. (118 mL) bottle, OTC, Distributed by: Major Pharmaceutical, 3 (September 2, 2016)
  • D-0496-2017 Class I — EYE WASH, 4 fl oz. (118 mL) bottle, OTC, Distributed by: Major Pharmaceutical, 3 (September 2, 2016)