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
D-0133-2018
Product summary
- Event
- Event 78773
- Status
- Terminated
- Classification
- Class III
- Quantity
- 2,488 200-bottles
- Official record key
drug-enforcement:D-0133-2018
Official wording
Reason: 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.
Code information: Lot # AH3842
Distribution pattern: Distributed nationwide in the USA
Derived failure modes
-
Foreign material or chemical contamination
Foreign Substance