FDA recall D-833-2015

Product

Paroxetine active pharmaceutical ingredient packaged in varying grams or kg in bags or drums, Attix Pharmaceuticals, 184 Front Street East, Unit 801, Toronto, Ontario M5A 4N3, Canada

Reason for recall

Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.

Distribution

Nationwide to compounding pharmacies and research organizations.

Key facts

Status

Terminated

Initiation date

2014-11-14

Report date

2015-04-29

Termination date

2015-10-07

Voluntary/Mandated

Voluntary: Firm initiated

Location

Toronto, Canada

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-833-2015