FDA recall D-1574-2014

Apotex Inc. · Class II · drug

Product

Paroxetine HCL Controlled-Release Tablets 12.5 mg, 30-count bottle, Rx only, Manufactured by GlaxoSmithKline, RTP, NC 27709, Manufactured for Apotex Corp., Weston, FL 33328, NDC 60505-3673-3

Reason for recall

Chemical Contamination: Product were manufactured with active pharmaceutical ingredient (API) batches contaminated with residual materials and solvents.

Distribution

Nationwide and Puerto Rico

Key facts

Status: Terminated
Initiation date: 2014-03-24
Report date: 2014-09-10
Termination date: 2014-09-23
Voluntary/Mandated: Voluntary: Firm initiated
Location: Toronto, Canada

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1574-2014