Apotex Voluntarily Recalls Paroxetine Products Due to API Contamination

Apotex Inc. is voluntarily recalling several lots of paroxetine hydrochloride (HCl) used in controlled-release tablets of various dosage forms and in oral suspensions due to batches of active pharmaceutical ingredients (APIs) being contaminated with residual materials and solvents. The Class II nationwide recall was voluntarily initiated by the company on March 24, 2014 and is ongoing and was reported in the September 10, 2014 Weekly Enforcement Report of the US Food and Drug Administration. The products were manufactured by GlaxoSmithKline (GSK) in Research Triangle Park, North Carolina and manufactured for Apotex Corp. of Weston, Florida.

Paroxetine HCl is the API in GSK’s antidepressant, Paxil. The recall applies to the following: five lots of paroxetine HCl controlled-release tablets, 12.5 mg in 30-count bottles; 10 lots of paroxetine HCl controlled-release tablets, 25 mg in 30-count bottles; three lots of paroxetine HCl controlled-release tablets, 37.5 mg in 30-count bottles; two lots of Paxil (paroxetine HCl) in oral suspensions, 10 mg/5 mL in 250-mL bottles; one lot of Paxil CR (paroxetine HCl) , 25 mg in 30-count bottles; one lot of Paxil CR (paroxetine HCl), 37.5 mg in 30-count bottles; one lot of Paxil (paroxetine HCl), 10 mg in 30-count bottles; one lot of Paxil (paroxetine HCl), 20 mg in 30-count bottles; and one lot of Paxil (paroxetine HCl), 40 mg in 30-count bottles

A Class II recall is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.

In July 2014, Mylan Inc. received from a US federal district court permanent injunction against GSK in relation to Paroxetine CR, the generic version of GSK’s antidepressant Paxil CR with GSK precluded from supplying product to Apotex, which marketed the product as an authorized generic. Mylan’s claims were based on 2007 agreements with GSK relating to Mylan’s abbreviated new drug application for paroxetine hydrochloride extended-release (ER) tablets. Pursuant to those agreements, Mylan obtained certain intellectual property rights from GSK and launched its generic paroxetine hydrochloride ER tablets in May 2008.  

Source: FDA

Leave a Reply

Your email address will not be published. Required fields are marked *