D-0101-2018 Class II Terminated
FDA drug recall D-0101-2018 was initiated by Zydus Pharmaceuticals USA Inc on November 20, 2017 and is designated Class II. Reason for recall: Presence of Foreign Tablets/Capsules: Risperidone Tablets were found in bottle of Paroxetine Tablets The recall status is terminated (terminated September 1, 2020). Affected quantity: 19812 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- December 6, 2017
- Initiation Date
- November 20, 2017
- Termination Date
- September 1, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 19812 bottles
Product Description
Paroxetine Tablets USP, 30 mg, a) 30 count (NDC 68382-099-06), b) 500 count (NDC 68382-099-05), and c) 1000 count (NDC 68382-099-10) count bottles, Rx Only, Manufactured by: Cadila Healthcare Ltd, Ahmedabad, India Distributed by: Zydus Pharmaceuticals USA, Inc., Pennington, NJ 08534
Reason for Recall
Presence of Foreign Tablets/Capsules: Risperidone Tablets were found in bottle of Paroxetine Tablets
Distribution Pattern
Nationwide
Code Information
a) Z701308, b) Z701309, c) Z701310 exp April 2019