April 13, 2020
Audience: Consumer, Health Professional, Pharmacy
FDA Publish Date:April 13, 2020 Company Announcement Date:January 28, 2018 — Kareway Products, Inc is voluntarily recalling 60,000 units 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.
Risk Statement: The product potentially could be calamitous for any population due to a probability of a potentially sight threatening eye infection or impairment. Kareway Products, Inc has not received any reports of adverse events related to this recall.
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 lot includes 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.
Kareway Products, Inc 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.
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 Online
- Regular Mail or Fax: 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
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.