Home / Recalls / Mylan Pharmaceuticals Inc. / D-0920-2017

D-0920-2017 Class III Terminated

Recalled by Mylan Pharmaceuticals Inc. — Morgantown, WV

Recall Details

Product Type
Drugs
Report Date
June 21, 2017
Initiation Date
May 9, 2017
Termination Date
February 14, 2018
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
11,624 pouches

Product Description

Montelukast Sodium Oral Granules, 4 mg pouch, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV --- NDC 0378-6040-93

Reason for Recall

Failed Impurities/Degradation Specifications; out of specification results for Sulphoxide Impurity and Total Impurities

Distribution Pattern

Nationwide

Code Information

Batch 3074707, exp 02/2018

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