July 2018 FDA Recall Dymista by Mylan Pharmaceuticals Inc.
D-1075-2018 - Presence of foreign substance

This Class II drug recall was voluntarily initiated by Mylan Pharmaceuticals Inc. on July 25, 2018 for the product Dymista. The FDA reported the reason for recall as presence of foreign substance. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-1075-2018

Reason for Recall
Presence of foreign substance: Potential for glass in the neck area of the glass bottles.
Initiated
07-25-2018
Reported
08-15-2018
Quantity
20,780 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
77850
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - 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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Mylan Pharmaceuticals Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S. Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
08-15-2019
Product Description About Product Description
Full technical description of the product.
Dymista (azelastine hydrochloride and fluticasone propionate) Nasal Spray, 137 mcg / 50 mcg per spray, packaged in a 23 g net fill weight, Rx only, Manufactured by: Cipla Ltd., Goa, India, M.L.,, NDC 0037-0245-23

Batch or Lot Expiration Information

Lot# : GA70246, GA70254, Exp 02/2019

Affected Packages Involved in this Recall

0037-0245-23 Dymista