Aru Pharma Artificial Tears - Discontinue Use
Voluntary Product Recall Statement
Aru Pharma Inc. (“Aru”) is voluntarily assisting in the recall of EzriCare Artificial Tears. It is strongly suggested that all consumers and healthcare practitioners immediately cease purchasing and using these products.
PRODUCT: Artificial Tears and Lubricant Eye Drops (carboxymethylcellulose sodium) 10 mg. in 1 mL, ½ fl. oz. (15 ml.) bottle. The product is packaged in a bottle, safely sealed, and placed in the following carton boxes: EzriCare NDC 79503-0101-15, UPC 3-79503-10115-7. The Artificial Tears were distributed in the United States and on the internet and can be identified by the photos below. The Artificial Tears are manufactured by Global Pharma Healthcare PVT LTD.
REASON FOR RECALL: Aru was recently made aware of an ongoing investigation conducted by the Centers for Disease Control and Prevention (“CDC”) stemming from a multistate cluster of Pseudomonas aeruginosa infections which implicated various over-the-counter artificial tears and eyedrops. In an abundance of caution, Aru is voluntarily in the manufacturer's recall of the Artificial Tears. ALL CONSUMERS AND HEALTHCARE PROVIDERS ARE SUGGESTED TO IMMEDIATELY DISCONTINUE USE OF THE ARTIFICIAL TEARS. The use of contaminated Artificial Tears can result in the risk of eye infections that could result in blindness, and in rare instances, death. Aru will be working with the Food and Drug Administration (“FDA”) regarding this issue.
MEANS OF COMMUNICATION: In the case of an adverse event resulting from the use of the Artificial Tears, a consumer may report the event to the FDA’s MedWatch Adverse Event Reporting program in the following manners:
• Online: http://www.fda.gov/MedWatch/report.htm
• Download the form at http://www.fda.gov/MedWatch/getforms.htm or request it by calling 1-800-332-1088.
Mail completed forms to the address on the form or fax to 1-800-FDA-0178.
Additionally, consumers with questions can reach out to the following:
1525 Prospect Street, Suite 204, Lakewood, NJ 08701; (+1) 718-502-6610; ezricare-info.com
Global Pharma Healthcare:
Aru Pharma Inc.