Montelukast Sodium Oral Granules, 4 mg pouch, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV --- NDC 0378-6040-93

FDA recall notice · announced June 21, 2017 · Mylan Pharmaceuticals

Class III FDA/FSIS Class III: use is not likely to cause adverse health consequences.

The product

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

Notes

Distribution: Nationwide
Lot/code information: Batch 3074707, exp 02/2018
Quantity: 11,624 pouches
Status: Terminated
Products in this recall event:
- Montelukast Sodium Oral Granules, 4 mg pouch, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV --- NDC 0378-6040-93 (D-0920-2017)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.