Paliperidone Extended-Release Tablets recall: Failed Dissolution
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
Why was Paliperidone Extended-Release Tablets 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 should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot: 1160682A, EXP. 06/18
- 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
- Recalling firm
- Teva Pharmaceuticals
- Quantity
- 360 bottles
- Distribution
- Nationwide in the US
- Recall date
- July 19, 2017
- Classification
- Class I
- Status
- Terminated
- Agency
- FDA (drug)