Multi-event September 2016 FDA Recall Drug by United Exchange Corporation

This Multi-event Class I drug recall was voluntarily initiated by United Exchange Corporation on September 2, 2016 for the product Drug. The FDA reported the reason for recall as non-sterility. The product was distributed Nationwide and the recall is currently terminated.

Reported Recall Events

D-0496-2017 TERMINATED D-0497-2017 TERMINATED D-0498-2017 TERMINATED D-0499-2017 TERMINATED

Recall Number: D-0496-2017

Reason for Recall
Non-Sterility: Direct evidence of contamination for 2 lots based on FDA samples.
Initiated
09-02-2016
Reported
03-08-2017
Quantity
46,080 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
75092
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
United Exchange Corporation
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide, Puerto Rico and Guyana
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-19-2017
Product Description About Product Description
Full technical description of the product.
EYE WASH, 4 fl oz. (118 mL) bottle, OTC, Distributed by: Major Pharmaceutical, 31778 Enterprise Drive, Livonia, MI 48150, Made in Korea, NDC 0904-6491-20

Batch or Lot Expiration Information

Lot# G15905, G15907, Exp 10/2018

Recall Number: D-0497-2017

Reason for Recall
Lack of assurance of sterility
Initiated
09-02-2016
Reported
03-08-2017
Quantity
112,320 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
75092
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
United Exchange Corporation
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide, Puerto Rico and Guyana
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-19-2017
Product Description About Product Description
Full technical description of the 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

Batch or Lot Expiration Information

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

Recall Number: D-0498-2017

Reason for Recall
Lack of assurance of sterility
Initiated
09-02-2016
Reported
03-08-2017
Quantity
77,184 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
75092
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
United Exchange Corporation
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide, Puerto Rico and Guyana
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-19-2017
Product Description About Product Description
Full technical description of the product.
Eye Wash, 4 fl oz (118 mL) bottle, OTC, Distributed by: United Exchange Corp., 17211 Valley View Ave., Cerritos, CA 90703, Made in Korea, UPC Code: 780707005828

Batch or Lot Expiration Information

Lot# G15901, G15902, G15903, G15904, Exp 07/31/2018; G16909, Exp 05/30/2019

Recall Number: D-0499-2017

Reason for Recall
Lack of assurance of sterility
Initiated
09-02-2016
Reported
03-08-2017
Quantity
190,710 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
75092
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
United Exchange Corporation
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide, Puerto Rico and Guyana
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-19-2017
Product Description About Product Description
Full technical description of the product.
EYE WASH, 4 fl oz. (118 mL) bottle, OTC, Distributed by: Major Pharmaceutical, 31778 Enterprise Drive, Livonia, MI 48150, Made in Korea, NDC 0904-6491-20

Batch or Lot Expiration Information

Lot# G15906, Exp 10/2018; G15910, G15911, G15912, Exp 11/2018; G16901, G16902, G16903, Exp 01/2019; G16905, G16906, G16907, Exp 02/2019; G16910, G16911, Exp 03/2019