Why it was recalled
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
Product description
SEVELAMER CARBONATE Tablet, 800 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 58468013001
Lot numbers, UPCs & expiration codes
SEVELAMER CARBONATE, Tablet, 800 mg has the following codes Pedigree: AD39858_4, EXP: 5/15/2014; Pedigree: AD70629_16, EXP: 5/29/2014; Pedigree: W002778, EXP: 6/6/2014; Pedigree: W002859, EXP: 6/7/2014; Pedigree: W003029, EXP: 6/11/2014; Pedigree: AD56917_4, EXP: 5/21/2014; Pedigree: AD73627_11, EXP: 5/30/2014; Pedigree: W002710, EXP: 6/6/2014; Pedigree: W002623, EXP: 6/4/2014; Pedigree: W003491, EXP: 6/20/2014.
Where it was sold
Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
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-637-2014
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jul 2, 2013
- FDA report date
- Jan 22, 2014
- Quantity
- 3,238 Tablets
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Aidapak Services, LLC
Original FDA data
Every field from FDA enforcement report D-637-2014, exactly as published.
Show all FDA fields
- City
- Vancouver
- State
- WA
- Status
- Terminated
- Country
- United States
- Event ID
- 65707
- Address
- 14301 Se 1st St
- Code information
- SEVELAMER CARBONATE, Tablet, 800 mg has the following codes Pedigree: AD39858_4, EXP: 5/15/2014; Pedigree: AD70629_16, EXP: 5/29/2014; Pedigree: W002778, EXP: 6/6/2014; Pedigree: W002859, EXP: 6/7/2014; Pedigree: W003029, EXP: 6/11/2014; Pedigree: AD56917_4, EXP: 5/21/2014; Pedigree: AD73627_11, EXP: 5/30/2014; Pedigree: W002710, EXP: 6/6/2014; Pedigree: W002623, EXP: 6/4/2014; Pedigree: W003491, EXP: 6/20/2014.
- Postal code
- 98684-3501
- Report date
- Jan 22, 2014
- Product type
- Drugs
- Recall number
- D-637-2014
- Classification
- Class II
- Recalling firm
- Aidapak Services, LLC
- Product quantity
- 3,238 Tablets
- Termination date
- Feb 7, 2014
- Reason for recall
- 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
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- SEVELAMER CARBONATE Tablet, 800 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 58468013001
- Distribution pattern
- Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
- Recall initiation date
- Jul 2, 2013
- Initial firm notification
- Telephone
- Center classification date
- Jan 16, 2014