PlainRecalls
FDA Drug Moderate Class II Terminated

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

Reported: September 20, 2017 Initiated: August 18, 2017 #D-1137-2017

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

Details

Units Affected
44800 bottles
Distribution
Nationwide within United States
Location
Pennington, NJ

Frequently Asked Questions

What product was recalled?
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. Recalled by Zydus Pharmaceuticals USA Inc. Units affected: 44800 bottles.
Why was this product recalled?
Presence of Foreign tablets/capsules: risperidone Tablets were found in bottle of paroxetine Tablets
Which agency issued this recall?
This recall was issued by the FDA Drug on September 20, 2017. Severity: Moderate. Recall number: D-1137-2017.