Why it was 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.
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
Lot numbers, UPCs & expiration codes
Lot # AH3842
Where it was sold
Distributed nationwide in the USA
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0133-2018
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Dec 12, 2017
- FDA report date
- Jan 3, 2018
- Quantity
- 2,488 200-bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Keryx Biopharmaceuticals, Inc.
Original FDA data
Every field from FDA enforcement report D-0133-2018, exactly as published.
Show all FDA fields
- City
- Boston
- State
- MA
- Status
- Terminated
- Country
- United States
- Event ID
- 78773
- Address
- 1 Marina Park Dr Fl 12
- Code information
- Lot # AH3842
- Postal code
- 02210-1832
- Report date
- Jan 3, 2018
- Product type
- Drugs
- Recall number
- D-0133-2018
- Classification
- Class III
- Recalling firm
- Keryx Biopharmaceuticals, Inc.
- Product quantity
- 2,488 200-bottles
- Termination date
- Oct 1, 2018
- 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- Distributed nationwide in the USA
- Recall initiation date
- Dec 12, 2017
- Initial firm notification
- Letter
- Center classification date
- Dec 26, 2017