Class I
Terminated
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
This recall has been terminated (originally issued July 19, 2017).
- Company
- Teva Pharmaceuticals
- Recall Initiated
- May 31, 2017
- Posted
- July 19, 2017
- Recall Number
- D-0960-2017
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 360 bottles
- Firm Location
- Horsham, PA, United States
- Official Source
- View on FDA website ↗
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.
Distribution
Nationwide in the US
Lot / Code Info
Lot: 1160682A, EXP. 06/18
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