D-0133-2018 Class III Terminated
FDA drug recall D-0133-2018 was initiated by Keryx Biopharmaceuticals, Inc. on December 12, 2017 and is designated Class III. 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 … The recall status is terminated (terminated October 1, 2018). Affected quantity: 2,488 200-bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- January 3, 2018
- Initiation Date
- December 12, 2017
- Termination Date
- October 1, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2,488 200-bottles
Product Description
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 Pattern
Distributed nationwide in the USA
Code Information
Lot # AH3842