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Teva recalls extended-release paliperidone due to dissolution failure
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Teva Pharmaceuticals recently announced a voluntary recall on one lot of 90-count, 3-mg bottles of paliperidone extended-release tablets to retail and consumers.
The recalled lot is number 1160682A, NDC 0591-3693-19, with a June 2018 expiration, distributed under the Actavis Pharma Inc. label between Dec. 12, 2016 and March 16, 2017.
The recall is due to the product failing for dissolution, which can result in less drug being absorbed, according to the FDA.
At the time of the release, Teva could not exclude the potential for additional tablets to be below specification.
An investigation conducted by Teva indicated the risk for consuming two or more consecutive doses of the recalled product was low. Further, no postmarketing adverse events due to lack of efficacy have been reported for this lot.
Teva issued an Urgent Drug Recall letter to its direct accounts and made arrangements for the recalled product to be returned to Inmar.
For more information:
Visit https://www.fda.gov/Safety/Recalls/default.htm.