FDA Recall D-0960-2017
Teva Pharmaceuticals · Horsham, PA
Class I — life-threatening Terminated 302 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
Product
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
Reason for recall
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.
Recall record
- Recall number
D-0960-2017- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- Nationwide in the US
- Recall initiated
- 2017-05-31
- Classified by FDA Center
- 2017-07-11
- FDA published
- 2017-07-19
- Terminated
- 2018-03-29
- Recalling firm
- Teva Pharmaceuticals
- Firm location
- Horsham, PA