PAROXETINE

Generic: PAROXETINE, PAROXETINE HYDROCHLORIDE

Chartwell RXManufacturer

ORALRoute

PAROXETINE HYDROCHLORIDEActive Substance

2016-06-10Original Approval

PAROXETINE is FDA application ANDA204744, sponsored by LANNETT CO INC. Any recalls listed below come from FDA drug enforcement reports, and reaction counts are the number of FAERS adverse event reports that mention the drug and that reaction; a report does not prove the drug caused it.

Recalls

Class II2014-03-24

Paroxetine HCL Controlled-Release Tablets 25 mg, 30-count bottle, Rx only, Manufactured by GlaxoSmithKline, RTP, NC 2770

Chemical Contamination: Product were manufactured with active pharmaceutical ingredient (API) batche

Class II2014-03-24

Paroxetine HCL Controlled-Release Tablets 37.5 mg, 30-count bottle, Rx only, Manufactured by GlaxoSmithKline, RTP, NC 27

Chemical Contamination: Product were manufactured with active pharmaceutical ingredient (API) batche

Class II2017-10-24

Paroxetine Tablets, USP, 30mg, 100 tablets (10 x 10) , Rx Only, Distributed by: American Health Packaging, Columbus, Ohi

Presence of Foreign Tablets/Capsules.

Class II2014-03-24

Paroxetine HCL Controlled-Release Tablets 12.5 mg, 30-count bottle, Rx only, Manufactured by GlaxoSmithKline, RTP, NC 27

Chemical Contamination: Product were manufactured with active pharmaceutical ingredient (API) batche

Class II2017-11-20

Paroxetine Tablets USP, 30 mg, a) 30 count (NDC 68382-099-06), b) 500 count (NDC 68382-099-05), and c) 1000 count (NDC

Presence of Foreign Tablets/Capsules: Risperidone Tablets were found in bottle of Paroxetine Tablets

Class III2017-06-22

Paroxetine Extended-Release Tablets USP, 12.5 mg, 30 count bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc

Failed Dissolution Specifications: out of specification observed in dissolution testing at 3 month

Class II2017-08-18

Paroxetine tablets USP, 30mg, 30-count bottles, Rx Only, Manufactured by: Cadila Healthcare Ltd, Ahmedabad, India Distri

Presence of Foreign tablets/capsules: risperidone Tablets were found in bottle of paroxetine Tablets

PAROXETINE

Recalls

Top Reported Reactions