Paliperidone Extended-release Tablets, 1.5 mg, 30 count bottles, Rx only, Mylan Pharmaceuticals, Inc., Morgantown, WV --- NDC 0378-3978-93
Reported: May 18, 2016 Initiated: February 12, 2016 #D-0840-2016
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.
Details
- Recalling Firm
- Mylan Pharmaceuticals Inc.
- Units Affected
- 2928 bottles
- Distribution
- Nationwide
- Location
- Morgantown, WV
Frequently Asked Questions
What product was recalled? ▼
Paliperidone Extended-release Tablets, 1.5 mg, 30 count bottles, Rx only, Mylan Pharmaceuticals, Inc., Morgantown, WV --- NDC 0378-3978-93. Recalled by Mylan Pharmaceuticals Inc.. Units affected: 2928 bottles.
Why was this product recalled? ▼
Failed Dissolution Specifications; three month stability time point.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on May 18, 2016. Severity: Moderate. Recall number: D-0840-2016.
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