Home / Recalls / Mylan Pharmaceuticals Inc. / D-0424-2019

D-0424-2019 Class II Terminated

Recalled by Mylan Pharmaceuticals Inc. — Morgantown, WV

Recall Details

Product Type
Drugs
Report Date
February 13, 2019
Initiation Date
February 1, 2019
Termination Date
September 9, 2019
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
10,390 bottles

Product Description

Dymista (azelastine hydrochloride and fluticasone propionate) Nasal Spray, 137 mcg/50 mcg per spray, 120 Metered Sprays, 23 g net fill weight bottle, Rx Only, Manufactured by: Cipla Ltd., Goa, India, M.L. No. 546; For: Meda Pharmaceuticals Inc., Somerset, New Jersey 08873-4120, NDC 0037-0245-23.

Reason for Recall

Defective Container: Potential for broken glass in the neck area of the glass bottles.

Distribution Pattern

Nationwide in the USA.

Code Information

Lot: GA70535, Exp. April 2019

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  • D-0774-2022 Class II — Rifampin for Injection, USP, 600 mg/vial, One Vial per carton, Rx only, Manufact (April 7, 2022)
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  • D-0049-2021 Class III — Candesartan Cilexetil and Hydrochlorothiazide Tablets, USP 32 mg/12.5 mg, packag (October 2, 2020)
  • D-1057-2020 Class III — Tacrolimus Capsules, USP 5mg, 100-count bottle, Rx only, Mylan Pharmaceuticals I (March 23, 2020)