Drug Safety Alerts

Eyesaline Eyewash Class I Recall

12/28/2016

On December 28, 2016, the United States Food and Drug Administration (FDA) issued a notice regarding a Class I Recall of Eyesaline Eyewash manufactured by Honeywell. This recall was issued as a precautionary measure due to a low risk of product contamination with Klebsiella pneumoniae. Although 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.

This recall affects lot number F16091-61 exp. 03/19. No other lot number of the product is subject to this recall.

This recall was originally issued August 22, 2016 to the retail-level. The FDA classified this recall as a Class I on December 28, 2016.

CVS Caremark Response:

Please note: This product is not carried by the CVS Caremark Mail Service Pharmacies.

For more information about this recall, health care providers may contact Honeywell Customer Care at 1‑800‑430-5490, Monday through Friday, 8:00 am through 6:30 pm (ET).  You may also contact the FDA consumer inquiry line at 1‑888‑INFO-FDA (1‑888-463-6332) or visit https://www.accessdata.fda.gov.