In recent days you may have received a VOLUNTARY recall letter issued by Altaire Pharmaceuticals involving several products distributed by OCuSOFT Inc. This a precautionary measure by the manufacturer, Altaire, who has initiated a RETAIL LEVEL recall due to management concerns regarding the sufficiency of Quality Assurance controls over critical systems in the manufacturing facility. The FDA has determined these issues indicate a lack of sterility assurance.
It is important to note that this recall is being issued to the RETAIL LEVEL and WILL NOT AFFECT PATIENTS OR CONSUMERS. Accordingly, no further communication or retrieval to or from patients/consumers is required. RETAIL, in this instance, is by way of definition, a recall of existing inventory and as previously noted would not affect your patients.
Clearly, this is disturbing and as disruptive to you as it has been to us and for that, we apologize. Unfortunately, we were not the only parties affected as we join with Walgreens, CVS, Wal-Mart, Accutome, Focus Laboratories, Prestige (Clear Eyes), Natural Ophthalmics, TRP/Target, Up & UP, Perrigo and others who were distributors of Altaire’s products.
Altaire advises as follows:
TO DATE ALTAIRE HAS NOT RECEIVED ANY REPORTS OF ADVERSE EVENTS FOR THE PRODUCTS.
TO DATE ALTAIRE HAS NOT OBTAINED ANY OUT OF SPECIFICATIONS RESULTS, INCLUDING STERILITY TESTING, FOR THE PRODUCTS.
OCuSOFT Inc. advises as follows:
Retaine® MGD® lubricating eyedrops, OCuSOFT® Lid Scrub® and the overwhelming bulk of OCuSOFT®’s products are not manufactured by Altaire and are not affected.
While other respected companies have experienced recalls, we nevertheless again regret this inconvenience. We pride ourselves on customer service and will be happy to assist you with any questions you may have.
About OCuSOFT, Inc.
OCuSOFT Inc. is a privately-held Richmond, TX USA-based eye and skin care company with an established reputation for innovation, particularly in Ocular Surface Disease (OSD). Since 1986, OCuSOFT® has served the ophthalmic industry with a unique selection of proprietary brands and has recently been rapidly expanding its presence in the skin care market. OCuSOFT®, most recognized for its #1 Doctor Recommended Brand of Eyelid Cleansers, OCuSOFT® Lid Scrub®, is dedicated to improving each patient's health by providing the highest quality products. For more information, please call 800-233-5469 or visit www.ocusoft.com.
Contact: Troy Smith, Vice President Sales & Marketing