The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0497-2017·Announced 2017-03-08

United Exchange Recalls Eye Irrigating Solution Due to Sterility Concerns

United Exchange Corporation is recalling 112,320 bottles of Eye Irrigating Solution because the product lacks assurance of sterility.

The agency’s classification

FDA (Drugs): Class II

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.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classification is FDA Class II, and the hazard involves a lack of sterility assurance for a product used on the eyes, which aligns with the 'Severe' criteria for significant injury risk or structural defects in medical/OTC products.

Plain-English summary

United Exchange Corporation is recalling 112,320 bottles of Eye Irrigating Solution, 4 fl oz (118 mL), OTC. The product is distributed by Rugby Laboratories and made in Korea. The recall is being conducted because the product lacks assurance of sterility.

The affected product is identified by NDC 0536-1083-97. Specific lot numbers and expiration dates include G15908 (Exp 10/2018), G15909 (Exp 01/2018), G16904 (Exp 01/2019), G16908 (Exp 02/2019), and G16912/G16913 (Exp 03/2019). The recall covers distribution in the United States, Puerto Rico, and Guyana.

Consumers should check their inventory for the specific lot numbers and expiration dates listed above. If they possess the recalled product, they should stop using it and contact the recalling firm or their healthcare provider for further instructions.

The recalled product

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
Manufacturer
United Exchange Corporation
Category
Drug — Ophthalmic
Hazard
Affected units
112,320

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 (11)

  • Lot # G15908
  • Exp 10/2018
  • G15909
  • Exp 01/2018
  • G16904
  • Exp 01/2019
  • G16908
  • Exp 02/2019
  • G16912
  • G16913
  • 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 →

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