D-1137-2017 Class II Terminated
FDA drug recall D-1137-2017 was initiated by Zydus Pharmaceuticals USA Inc on August 18, 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 January 6, 2020). Affected quantity: 44800 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- September 20, 2017
- Initiation Date
- August 18, 2017
- Termination Date
- January 6, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 44800 bottles
Product Description
Paroxetine tablets USP, 30mg, 30-count bottles, Rx Only, Manufactured by: Cadila Healthcare Ltd, Ahmedabad, India Distributed by: Zydus Pharmaceuticals USA, Inc., Pennington, NJ 08534, NDC 68382-099-06, UPC 3 6838209906 8
Reason for Recall
Presence of Foreign tablets/capsules: risperidone Tablets were found in bottle of paroxetine Tablets
Distribution Pattern
Nationwide within United States
Code Information
Lot #: Z701133, Exp 03/19