Sevelamer HCl Tablets Recalled for Potential Labeling Error
Aidapak Services, LLC is recalling Sevelamer HCl tablets that may be mislabeled as Ranolazine ER due to a labeling mixup.
What this means for you
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, which typically corresponds to a Moderate severity score (2) when no specific hospitalizations or severe injuries are reported, fitting the criteria for minor labeling errors or low-risk contamination.
Plain-English summary
Aidapak Services, LLC is recalling Sevelamer HCl Tablets, 800 mg, NDC 58468002101, due to a labeling mixup. The affected product may be potentially mislabeled as Ranolazine ER, Tablet, 500 mg, NDC 61958100301. The specific pedigree for the recalled Sevelamer HCl tablets is W002858, with an expiration date of 6/7/2014.
The repacked drugs were distributed in Arizona, California, Oregon, and Washington. The recall is classified as Class II by the FDA, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
Consumers and healthcare providers should check their inventory for Sevelamer HCl Tablets, 800 mg, with pedigree W002858 and expiration date 6/7/2014. If found, the product should be quarantined and returned to the distributor or the recalling firm, Aidapak Services, LLC, for further instructions.
The recalled product
- Product
- SEVELAMER HCl Tablet, 800 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 58468002101
- Manufacturer
- Aidapak Services, LLC
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 180
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 (3)
- SEVELAMER HCl Tablet
- 800 mg has the following code Pedigree: W002858
- EXP: 6/7/2014.
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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