The Recall Desk
SevereFDA (Drugs)·D-0499-2017·Announced 2017-03-08

United Exchange Recalls Eye Wash Bottles Due to Sterility Concerns

United Exchange Corporation is recalling 190,710 bottles of Eye Wash due to a lack of assurance of sterility. The product was distributed nationwide, in Puerto Rico, and in Guyana.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II. According to the rubric, an FDA Class II recall involving a significant hazard such as lack of sterility in a medical product corresponds to a Severe severity score.

Plain-English summary

United Exchange Corporation is recalling 190,710 bottles of 4 fl oz. (118 mL) Eye Wash, OTC. The product is distributed by Major Pharmaceutical and made in Korea. The recall is being conducted due to a lack of assurance of sterility.

The affected product is identified by NDC 0904-6491-20. Specific lot numbers and expiration dates include G15906 (Exp 10/2018), G15910, G15911, and G15912 (Exp 11/2018), G16901, G16902, and G16903 (Exp 01/2019), G16905, G16906, and G16907 (Exp 02/2019), and G16910 and G16911 (Exp 03/2019).

The recalled Eye Wash was distributed nationwide, in Puerto Rico, and in Guyana. Consumers should check their inventory for the specific lot numbers and expiration dates listed above and stop using the product if it matches the recall details.

The recalled product

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
Manufacturer
United Exchange Corporation
Category
Drug — Ophthalmic
Hazard
Affected units
190,710

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (17)

  • 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

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 4 recalled by United Exchange Corporation under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 4 products in this recall →

Related recalls

Same manufacturer · United Exchange Corporation

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Same hazard · lack of sterility

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