Systane Balance FDA Alerts
The FDA Alert(s) below may be specifically about Systane Balance or relate to a group or class of drugs which include Systane Balance (ocular lubricant).
MedWatch Safety Alerts are distributed by the FDA and published by Drugs.com. Following is a list of possible medication recalls, market withdrawals, alerts and warnings. For the latest FDA MedWatch alerts, go here.
Recent FDA Alert(s) for ocular lubricant
Altaire Pharmaceuticals Carboxymethylcellulose Sodium 0.5 Percent Ophthalmic Solution Sold Under Wal-Mart, CVS, and Target Brands: Recall - Preservative May Not Be Effective Through Expiry
Sep 8, 2013
Audience: Consumer, Eye Care, Pharmacy, Patient, Health Professional
ISSUE: Altaire Pharmaceuticals, Inc., announced that it is voluntarily recalling a total of nine (9) lots of Carboxymethylcellulose Sodium 0.5% Ophthalmic Solution, 30 mL, to the consumer level. Due to complaints of mold found in the 30 mL bottles after use, concerns regarding the effectiveness of the preservative after use and handling of the product by consumers have prompted the recall.
A product whose preservative may not be effective could lead to the use of a contaminated product which creates a potential risk for eye infection.
BACKGROUND: Carboxymethylcellulose Sodium 0.5% Ophthalmic Solution is a non-prescription (OTC) drug product used to relieve dryness of the eye and packaged in a plastic bottle inside a unit box.
The product is labeled as follows (refer the Firm Press Release for a detailed product list containing affected lot numbers):
- equate Restore Tears Lubricant Eye Drops Carboxymethylcellulose Sodium 0.5%, Sterile, 1 FL OZ (30 mL) - Distributed by Wal-Mart Stores, Inc.
- Lubricant EYE DROPS FOR MILD TO MODERATE DRY EYE, STERILE, 1 FL OZ (30 mL), for Mild to Moderate Dry Eye - Distributed by CVS Pharmacy, Inc.
- lubricant eye drops for mild to moderate dry eye, STERILE, 1 FL OZ (30 mL) - Dist. by Target Corp.
RECOMMENDATION: Consumers who have the product with any of the lot numbers listed in the Firm Press Release should stop use of the product immediately and return it to the place of purchase.
Consumers with questions regarding this recall can contact Altaire Pharmaceuticals at 1-800-258-2471, Monday – Friday from 9 am – 5 pm ET. 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.accessdata.fda.gov/scripts/medwatch/index.cfm
- 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
[09/06/2013 - Firm Press Release - FDA]