Teva Pharmaceuticals recalls Paliperidone Extended-Release Tablets, 3 mg, 90 count bottles, Rx only, Manufactured by: Actavis Laboratories FL, Inc.,
Recalled July 19, 2017 · FDA recall D-0960-2017 · Teva Pharmaceuticals
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. · FDA Class I
Units
360 bottles
Sold at
Nationwide in the US
Description
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.
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
Manufacturer(s)
Teva Pharmaceuticals
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →