Mylan Pharmaceuticals Inc. recalls Paliperidone Extended-release Tablets, 1.5 mg, 30 count bottles, Rx only, Mylan Pharmaceuticals, Inc., Morgantown, WV -…
- Recall date
- February 12, 2016
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- D-0840-2016
- FDA classification
- Class II
- Brand / firm
- Mylan Pharmaceuticals Inc.
- Sold / distributed
- Nationwide
Why it was recalled
Failed Dissolution Specifications; three month stability time point.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Paliperidone Extended-release Tablets, 1.5 mg, 30 count bottles, Rx only, Mylan Pharmaceuticals, Inc., Morgantown, WV --- NDC 0378-3978-93
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