Class II · Moderate risk Terminated
PALIPERIDONE EXTENDED-RELEASE TABLETS, 9 mg, 100 Tablets per carton (10 x 10 blister packs), Rx only, Manufactured by: Sun…
Reason Failed Dissolution Specifications
Paliperidone Extended-release Tablets, 1.5 mg, 30 count bottles, Rx only, Mylan…
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Failed Dissolution Specifications; three month stability time point.
What was recalled
Paliperidone Extended-release Tablets, 1.5 mg, 30 count bottles, Rx only, Mylan Pharmaceuticals, Inc., Morgantown, WV --- NDC 0378-3978-93
- Recalling firm
- Mylan Pharmaceuticals Inc.
- NDC code
- 0378-3978-93
- Origin
- WV, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0840-2016
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Other Paliperidone recalls
See all
Class II · Moderate risk Terminated
Paliperidone Extended Release Tablets 9 mg, packaged in a) 30-count bottle(NDC 0591-3695-30) , b) 90-count bottle (NDC…
Reason Defective Delivery System: There is a potential for some tablets to be missing the laser drilling which might affect drug release.
Class II · Moderate risk Terminated
Paliperidone Extended Release Tablets 3 mg, packaged in a) 30-count bottle(NDC 0591-3693-30), b) 90-count bottle…
Reason Defective Delivery System: There is a potential for some tablets to be missing the laser drilling which might affect drug release.
Class I · High risk Terminated
Paliperidone Extended-Release Tablets, 3 mg, 90 count bottles, Rx only, Manufactured by: Actavis Laboratories FL, Inc., Fort…
Reason Failed Dissolution Specifications: Drug release test result, obtained during routine 9-month stability testing, which was below specification for one…
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