Drug product
Montelukast Sodium Oral Granules, 4 mg pouch, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV --- NDC 0378-6040-93
D-0920-2017
Product summary
- Event
- Event 77430
- Status
- Terminated
- Classification
- Class III
- Quantity
- 11,624 pouches
- Official record key
drug-enforcement:D-0920-2017
Official wording
Reason: Failed Impurities/Degradation Specifications; out of specification results for Sulphoxide Impurity and Total Impurities
Code information: Batch 3074707, exp 02/2018
Distribution pattern: Nationwide
Derived failure modes
-
Potency or specification failure
out of specification