Montelukast Sodium Oral Granules, 4 mg pouch, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV --- NDC 0378-6040-93
Reported: June 21, 2017 Initiated: May 9, 2017 #D-0920-2017
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
Details
- Recalling Firm
- Mylan Pharmaceuticals Inc.
- Units Affected
- 11,624 pouches
- Distribution
- Nationwide
- Location
- Morgantown, WV
Frequently Asked Questions
What product was recalled? ▼
Montelukast Sodium Oral Granules, 4 mg pouch, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV --- NDC 0378-6040-93. Recalled by Mylan Pharmaceuticals Inc.. Units affected: 11,624 pouches.
Why was this product recalled? ▼
Failed Impurities/Degradation Specifications; out of specification results for Sulphoxide Impurity and Total Impurities
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on June 21, 2017. Severity: Low. Recall number: D-0920-2017.
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