Aidapak Recalls Sevelamer Carbonate Tablets Due to Labeling Mixup
Aidapak Services, LLC is recalling Sevelamer Carbonate tablets because they may be mislabeled as other prescription drugs.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II and involves a labeling mixup, which fits the rubric criteria for moderate severity involving minor labeling errors or low-risk contamination.
Plain-English summary
Aidapak Services, LLC is recalling Sevelamer Carbonate Tablet, 800 mg, NDC 58468013001, due to a labeling mixup. The recalled tablets may be potentially mislabeled as other prescription medications, including tizanidine HCl, levothyroxine sodium, quetiapine fumarate, and valsartan.
The repacked drugs were distributed in Arizona, California, Oregon, and Washington. The recall involves 3,238 tablets with specific pedigree codes and expiration dates ranging from May to June 2014.
Consumers should check their medication for the specific NDC and pedigree codes listed in the recall notice. If the medication matches the recalled product, they should stop using it and contact their healthcare provider or pharmacist for guidance.
The recalled product
- Product
- SEVELAMER CARBONATE Tablet, 800 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 58468013001
- Manufacturer
- Aidapak Services, LLC
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 3,238
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 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
- Pedigree: W002623
- EXP: 6/4/2014
- Pedigree: W003491
Distribution
Part of a larger recall action
This product is one of 273 recalled by Aidapak Services, LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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