FDA Drug Class I — Most Serious

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

Hazard

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.

Products

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,
Brand
Teva Pharmaceuticals
UPC
Lot: 1160682A, EXP. 06/18

Units Affected

360 bottles