Home / Recalls / Mylan Pharmaceuticals Inc. / D-1075-2018

D-1075-2018 Class II Terminated

Recalled by Mylan Pharmaceuticals Inc. — Morgantown, WV

Recall Details

Product Type
Drugs
Report Date
August 15, 2018
Initiation Date
July 25, 2018
Termination Date
August 15, 2019
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
20,780 bottles

Product Description

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

Reason for Recall

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

Distribution Pattern

U.S. Nationwide

Code Information

Lot #: GA70246, GA70254, Exp 02/2019

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