Reported May 18, 2016 · Terminated
Paliperidone Extended-release Tablets, 1.5 mg, 30 count bottles, Rx only, Mylan Pharmaceuticals, Inc., Morgantown, WV…
Mylan Pharmaceuticals Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Mylan Pharmaceuticals Inc. · 781 Chestnut Ridge Rd · Morgantown, WV · 26505-2730
Is this the product you have?
- Paliperidone Extended-release Tablets, 1.5 mg, 30 count bottles, Rx only, Mylan Pharmaceuticals, Inc., Morgantown, WV --- NDC 0378-3978-93
- Lot codes and dates
- Lot
200544101/2017
- Code0378-3978-93
- Lot
- Amount recalled
- 2928 bottles
Where it was sold
- Nationwide
Why it was recalled
Failed Dissolution Specifications; three month stability time point.
This product could cause temporary or reversible health problems — stop using it.
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