FDA recall D-0133-2018

Keryx Biopharmaceuticals, Inc. · Class III · drug

Product

Auryxia (ferric citrate) tablets, 210 mg , 200-count bottles, RX ONLY, Manufactured for and distributed by: Keryx Biopharmaceticals, Inc. One Marina Park Drive, 12th Floor, Boston, MA 02210 USA. NDC 59922-631-01

Reason for recall

Presence of Foreign Substance: Reports have been received of damaged StripPax packets containing silica gel desiccant potentially allowing the silica gel granules to make contact with Auryxia tablets in the bottle.

Distribution

Distributed nationwide in the USA

Key facts

Status: Terminated
Initiation date: 2017-12-12
Report date: 2018-01-03
Termination date: 2018-10-01
Voluntary/Mandated: Voluntary: Firm initiated
Location: Boston, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0133-2018