US Drug Recall Register
Class II · Moderate risk Terminated Initiated Aug 6, 2018 (8 years ago)

Paliperidone Extended Release Tablets 9 mg

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Why it was recalled

Defective Delivery System: There is a potential for some tablets to be missing the laser drilling which might affect drug release.

What was recalled

Paliperidone Extended Release Tablets 9 mg, packaged in a) 30-count bottle(NDC 0591-3695-30) , b) 90-count bottle (NDC 0591-3695-19), Rx only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL 33314, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054

Recalling firm
Teva Pharmaceuticals USA
NDC code
0591-3695-30
Origin
PA, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-0097-2019

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 3 mg

Reason Defective Delivery System: There is a potential for some tablets to be missing the laser drilling which might affect drug release.

Teva Pharmaceuticals USA NDC 0591-3693-30 D-0096-2019
Class I · High risk Terminated

Paliperidone Extended-Release Tablets

Reason Failed Dissolution Specifications: Drug release test result, obtained during routine 9-month stability testing, which was below specification for one tablet. Teva cannot at this time exclude the potential for additional tablets to be below specification.

Teva Pharmaceuticals D-0960-2017
Class II · Moderate risk Terminated

Paliperidone Extended-release Tablets

Reason Failed Dissolution Specifications; three month stability time point.

Mylan Pharmaceuticals Inc. NDC 0378-3978-93 D-0840-2016