FDA recall D-1137-2017

Product

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

Nationwide within United States

Key facts

Status

Terminated

Initiation date

2017-08-18

Report date

2017-09-20

Termination date

2020-01-06

Voluntary/Mandated

Voluntary: Firm initiated

Location

Pennington, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1137-2017