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):
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:
[09/06/2013 - Firm Press Release - FDA]