US Drug Recall Register
Class II · Moderate risk Terminated Initiated Jul 2, 2013 (13 years ago)

SEVELAMER HCl Tablet

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Why it was recalled

Labeling:Label Mixup; SEVELAMER HCl Tablet, 800 mg may be potentially mislabeled as RANOLAZINE ER, Tablet, 500 mg, NDC 61958100301, Pedigree: W002857, EXP: 6/7/2014.

What was recalled

SEVELAMER HCl Tablet, 800 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 58468002101

Recalling firm
Aidapak Services, LLC
Origin
WA, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-636-2014

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.

Other Sevelamer recalls

See all
Class III · Low risk Ongoing

Sevelamer Carbonate for Oral Suspension 0.8g packets

Reason Labeling: Incorrect or Missing Lot and/or Exp Date. Missing lot number and expiration dates on packets

Dr. Reddy's Laboratories, Inc. NDC 43598-478-90 D-0625-2024
Class II · Moderate risk Terminated

Sevelamer HCl active pharmaceutical ingredient packaged in…

Reason Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.

Attix Pharmaceuticals D-892-2015
Class II · Moderate risk Terminated

SEVELAMER CARBONATE Tablet

Reason Labeling:Label Mixup; SEVELAMER CARBONATE Tablet, 800 mg may be potentially mislabeled as tiZANidine HCl, Tablet, 2 mg, NDC 55111017915, Pedigree: AD46265_16, EXP: 5/15/2014; LEVOTHYROXINE SODIUM, Tablet, 88 mcg, NDC 00781518392, Pedigree: AD70629_13, EXP: 5/29/2014; QUEtiapine FUMARATE, Tablet, 100 mg, NDC 60505313301, Pedigree: W002777, EXP: 6/6/2014; VALSARTAN, Tablet, 160 mg, NDC 0007803

Aidapak Services, LLC D-637-2014