Apotex Recalls Glass-Containing Lot of Nasal Spray

MAY 31, 2018
Kevin Kunzmann
nasal spray, recall, glass, fdaApotex Corporation has announced a voluntary recall of 1 lot of fluticasone propionate nasal spray after it was found to have small glass particles in it.

The 120 metered 50-mcg nasal spray products were found to contain glass, which could block the actuator and impact the pump’s functionality. The therapy is indicated for the treatment of seasonal and perennial allergic rhinitis, as well as the management of sinus pain and pressure associated with rhinitis in patients aged 4-17 years old.

The issue that drove the recall was initially discovered through a customer complaint, according to the US Food and Drug Administration (FDA). The product is a nationwide-distributed therapy.

Apotex has already notified wholesalers and distributors via a recall letter, in order to arrange returns of affected products. The FDA advises consumers and institutiosn with any existing inventory of the lot subject to the recall to stop use and distribution of remaining units, and to quarantine the products immediately. Health care providers in organizations should be informed, as should any accounts or additional locations who may have received the product for retail purposes.

Reports adverse reactions or quality problems experienced with the use of the product can be directed to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail, or by fax.

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