D-0840-2016 Class II Terminated
FDA drug recall D-0840-2016 was initiated by Mylan Pharmaceuticals Inc. on Feb 12, 2016 and is designated Class II. Reason for recall: Failed Dissolution Specifications; three month stability time point. The recall status is terminated (terminated Oct 26, 2016). Affected quantity: 2928 bottles.
Recall details
- Product Type
- Drugs
- Report Date
- May 18, 2016
- Initiation Date
- Feb 12, 2016
- Termination Date
- Oct 26, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2928 bottles
Product description
Paliperidone Extended-release Tablets, 1.5 mg, 30 count bottles, Rx only, Mylan Pharmaceuticals, Inc., Morgantown, WV --- NDC 0378-3978-93
Reason for recall
Failed Dissolution Specifications; three month stability time point.
Distribution pattern
Nationwide
Code information
Lot: 2005441, 01/2017, Code: 0378-3978-93
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0840-2016
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026