D-0960-2017 Class I Terminated
FDA drug recall D-0960-2017 was initiated by Teva Pharmaceuticals on May 31, 2017 and is designated Class I. 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 poten… The recall status is terminated (terminated March 29, 2018). Affected quantity: 360 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- July 19, 2017
- Initiation Date
- May 31, 2017
- Termination Date
- March 29, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 360 bottles
Product Description
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
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 Pattern
Nationwide in the US
Code Information
Lot: 1160682A, EXP. 06/18