Reported Jun 21, 2017 · Terminated
Montelukast Sodium Oral Granules, 4 mg pouch, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV --- NDC 0378-6040-93
Mylan Pharmaceuticals Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Mylan Pharmaceuticals Inc. · 781 Chestnut Ridge Rd · Morgantown, WV · 26505-2730
Is this the product you have?
- Montelukast Sodium Oral Granules, 4 mg pouch, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV --- NDC 0378-6040-93
- Lot codes and dates
Batch 3074707exp 02/2018
- Amount recalled
- 11,624 pouches
Where it was sold
- Nationwide
Why it was recalled
Failed Impurities/Degradation Specifications; out of specification results for Sulphoxide Impurity and Total Impurities
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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