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
Reported: January 3, 2018 Initiated: December 12, 2017 #D-0133-2018
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.
Details
- Recalling Firm
- Keryx Biopharmaceuticals, Inc.
- Units Affected
- 2,488 200-bottles
- Distribution
- Distributed nationwide in the USA
- Location
- Boston, MA
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Keryx Biopharmaceuticals, Inc.. Units affected: 2,488 200-bottles.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on January 3, 2018. Severity: Low. Recall number: D-0133-2018.
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