FDA-Drug2016-05-18Class II

Paliperidone Extended-release Tablets, 1.5 mg, 30 count bottles, Rx only, Mylan Pharmaceuticals, Inc., Morgantown, WV --- NDC 0378-3978-93

Mylan Pharmaceuticals Inc.
Hazard

Failed Dissolution Specifications; three month stability time point.

Sold states
Nationwide
Affected count
2928 bottles
Manufactured in
781 Chestnut Ridge Rd, N/A, Morgantown, WV, United States
Products
Paliperidone Extended-release Tablets, 1.5 mg, 30 count bottles, Rx only, Mylan Pharmaceuticals, Inc., Morgantown, WV --- NDC 0378-3978-93

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0840-2016

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