D-0920-2017 Class III Terminated
FDA drug recall D-0920-2017 was initiated by Mylan Pharmaceuticals Inc. on May 9, 2017 and is designated Class III. Reason for recall: Failed Impurities/Degradation Specifications; out of specification results for Sulphoxide Impurity and Total Impurities The recall status is terminated (terminated Feb 14, 2018). Affected quantity: 11,624 pouches.
Recall details
- Product Type
- Drugs
- Report Date
- Jun 21, 2017
- Initiation Date
- May 9, 2017
- Termination Date
- Feb 14, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 11,624 pouches
Product description
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
Distribution pattern
Nationwide
Code information
Batch 3074707, exp 02/2018
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0920-2017
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026