Recalls / Class III
Class IIID-0920-2017
Product
Montelukast Sodium Oral Granules, 4 mg pouch, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV --- NDC 0378-6040-93
- Affected lot / code info
- Batch 3074707, exp 02/2018
Why it was recalled
Failed Impurities/Degradation Specifications; out of specification results for Sulphoxide Impurity and Total Impurities
Recalling firm
- Firm
- Mylan Pharmaceuticals Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 781 Chestnut Ridge Rd, N/A, Morgantown, West Virginia 26505-2730
Distribution
- Quantity
- 11,624 pouches
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2017-05-09
- FDA classified
- 2017-06-15
- Posted by FDA
- 2017-06-21
- Terminated
- 2018-02-14
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0920-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.