Recall record at a glance
| Official record | D-637-2014 |
|---|---|
| Category | Drug Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | Aidapak Services, LLC |
| Report date | Jan 22, 2014 |
| Recall initiation date | Jul 2, 2013 |
| Quantity | 3,238 Tablets |
| Location | Vancouver, WA, United States |
Official product description
SEVELAMER CARBONATE Tablet, 800 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 58468013001
Why the product 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
Distribution information
Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Telephone.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
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