February 2, 2018
Audience: Consumer, Pharmacy, Risk Manager
ISSUE: Kareway Products, Inc is voluntarily recalling 60,000 lots of Gericare Eye Wash, Sterile Eye Irrigation Solution, 4 fluid ounces to the hospital, retail or consumer level. The product has been found to have potential microbial contamination which compromises sterility. Use of the affected product could be calamitous for any population due to a probability of a potentially sight threatening eye infection or impairment.
BACKGROUND: The product is used as eye wash to clean, refresh, soothe eyes for daily use or emergency eye cleansing by flushing foreign material. It is packaged in 4 fluid ounce (118 ml) bottles. The affected Gericare Eye Wash, Sterile Eye Irrigation Solution lots include the following Lot#86041601 and expiration date of 09/2019. The product can be identified by UPC 3-57896-18604-3. The product was distributed nationwide to wholesale businesses.
RECOMMENDATION: Kareway Products is notifying its distributors and customers by recall letter and is arranging for return or disposal of all recalled products. Consumers and businesses that have product which is being recalled should stop using and selling them immediately.
Consumers with questions regarding this recall can contact the Recall Department at 310-532-0009 or firstname.lastname@example.org available Monday through Fridays from 08:30 am to 05:30 pm (Pacific Time). Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:
- Complete and submit the report Online: www.fda.gov/MedWatch/report
- Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
[01/29/2018 – Press Release – Kareway Products]