FDAClass IIAugust 15, 2018

Dymista recall

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

Why was Dymista recalled?

Presence of foreign substance: Potential for glass in the neck area of the glass bottles.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot #: GA70246, GA70254, Exp 02/2019

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
Recalling firm
Mylan Pharmaceuticals Inc.
Quantity
20,780 bottles
Distribution
U.S. Nationwide
Recall date
August 15, 2018
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls