FDA recall D-1575-2014

Apotex Inc. · Class II · drug

Product

PAXIL (Paroxetine HCL) Oral Suspension 10 mg/5 mL - 250 mL bottle, Rx Only, Manufactured by GlaxoSmithKline, RTP, NC 27709. Distributed by Apotex Corp., Westin, FL 33326, NDC 60505-0402-5

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-1575-2014