US Drug Recall Register
Class I · High risk Terminated Initiated May 31, 2017 (9 years ago)

Paliperidone Extended-Release Tablets

Class I — High risk. Reasonable probability of serious harm or death.

Why it was recalled

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.

What was recalled

Paliperidone Extended-Release Tablets, 3 mg, 90 count bottles, Rx only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL 33314 USA Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054, USA, NDC: 0591-3693-19

Recalling firm
Teva Pharmaceuticals
Origin
PA, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-0960-2017

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

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 0591-3695-30 D-0097-2019
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 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