Mylan Pharmaceuticals Inc. recalls Montelukast Sodium Oral Granules, 4 mg pouch, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV --- NDC 0378-6040-93
- Recall date
- May 9, 2017
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- D-0920-2017
- FDA classification
- Class III
- Brand / firm
- Mylan Pharmaceuticals Inc.
- Sold / distributed
- Nationwide
Why it was recalled
Failed Impurities/Degradation Specifications; out of specification results for Sulphoxide Impurity and Total Impurities
Class III means the product violates regulations but is not likely to cause harm.
What was recalled
Montelukast Sodium Oral Granules, 4 mg pouch, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV --- NDC 0378-6040-93
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