Montelukast Sodium Oral Granules recall: Impurity Out of Spec
Montelukast Sodium Oral Granules, 4 mg pouch, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV --- NDC 0378-6040-93
Why was Montelukast Sodium Oral Granules recalled?
Failed Impurities/Degradation Specifications; out of specification results for Sulphoxide Impurity and Total Impurities
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Batch 3074707, exp 02/2018
- Product
- Montelukast Sodium Oral Granules, 4 mg pouch, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV --- NDC 0378-6040-93
- Recalling firm
- Mylan Pharmaceuticals Inc.
- Quantity
- 11,624 pouches
- Distribution
- Nationwide
- Recall date
- June 21, 2017
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (drug)