Class III
Terminated
Montelukast Sodium Oral Granules, 4 mg pouch, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV --- NDC 0378-6040-93
- Company
- Mylan Pharmaceuticals Inc.
- Recall Initiated
- May 9, 2017
- Posted
- June 21, 2017
- Recall Number
- D-0920-2017
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 11,624 pouches
- Firm Location
- Morgantown, WV, United States
Reason for Recall
Failed Impurities/Degradation Specifications; out of specification results for Sulphoxide Impurity and Total Impurities
Distribution
Nationwide
Lot / Code Info
Batch 3074707, exp 02/2018
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