Nearly 10,000 bottles of eyewash recalled, FDA announced

Agency says stop using solution, potential for eyesight threats

Posted August 30, 2016

The U.S. Food and Drug Administration (FDA) announced that Honeywell is voluntarily recalling one production lot of 32-ounce bottles of Eyesaline Eyewash solution, which is used for emergency eye rinsing after an injury.

Although no injuries have been reported and the FDA has not found any contamination in its batch testing, the voluntary recall is a precautionary measure due to a low risk of product contamination with Klebsiella pneumoniae. Although the bacteria are found in the normal flora of the mouth and skin, if the contaminant were present in a bottle, there is a potential for it to result in infections that may be sight-threatening.

Eyesaline Eyewash is sold through industrial sales distributors. Approximately 9,700 32-ounce bottles with lot number F16091-61 are subject to recall. No other lot number of the product is subject to this recall.

FDA says all of Honeywell’s distributors who received this lot have been notified by phone, e-mail, and certified mail, and have been instructed to notify their customers.

Distributors must stop distribution of the affected product and return it to Honeywell for credit or replacement. Commercial-industrial users of the product should also check whether their Eyesaline Eyewash is subject to recall. If it is, customers should stop using the solution and contact their distributor for replacement or credit.

The affected product and lot number can be identified as follows:

  • Product: 32 ounce Eyesaline Eyewash
  • Lot number: F16091-61 (no other lot number is subject to recall)
  • The lot number can be found on the outside of the product case and on individual bottles.

Customers with questions regarding this recall can contact their distributor or Honeywell Customer Care at (800) 430-5490, Monday – Friday, and 8:00 am – 6:30 pm EST. Customers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this product.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail, or by fax.

  • Complete and submit the report on the FDA website.
  • Regular mail or fax: Download the form on the FDA website or call (800) 332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to (800) FDA-0178.

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