Mylan Pharmaceuticals Inc has initiated a voluntary recall of a nasal spray manufactured by Indian pharma company Cipla. It has cited defect in the container as the reason for recalling 10,390 bottles of Dymista in the US.
In a notification on the US Food and Drug Administration (FDA) website last week, it said the products were manufactured at Cipla's Goa unit for Meda Pharmaceuticals Inc, a subsidiary of Mylan. The reason for the ongoing recall was given as the potential for broken glass in the neck area of the glass bottles.
Dymista (azelastine hydrochloride and fluticasone propionate) is a prescription-only nasal spray, formulated as a white, uniform metered-spray suspension for intranasal administration. The product comes in 137 mcg/ 50 mcg per spray, 120 metered sprays, 23 g net fill weight bottle with an expiry in April 2019.
Dymista nasal spray is indicated for the relief of symptoms of seasonal allergic rhinitis in patients six years of age and older who require treatment with both azelastine hydrochloride and fluticasone propionate for symptomatic relief.
The class II recall was initiated by the firm on February 1, 2019. A class II recall is a situation in which use of, or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
In August last year as well a recall was initiated by the firm when two batches were recalled at the retail level for a similar reason. It had then said that the potential risk to the nasal mucosa, although could not be fully excluded if the product with broken glass was administered, based on clinical and external factors, that risk was considered low. The batches were distributed in the US in September 2017 and had an expiry date of February 2019.
In 2013, Cipla, a strong player in respiratory therapy, granted global commercialisation rights for Dymista nasal spray to the then Swedish pharma company Meda AB, which was later acquired by Mylan in 2016.
