Rifaximin Tablets Recalled for Potential Mislabeling as Toprol
Aidapak Services is recalling Rifaximin 200 mg tablets that may be mislabeled as Toprol 25 mg. The repacked drugs were distributed in four western states.
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 for minor labeling errors or low-risk contamination.
Plain-English summary
Aidapak Services, LLC is recalling Rifaximin 200 mg tablets (NDC 65649030103) that may be potentially mislabeled as Toprol 25 mg tablets (NDC 00143117201). The recall is due to a labeling mixup identified during the repacking process.
The affected repacked drugs were distributed in Arizona, California, Oregon, and Washington. The specific product code for the recalled Rifaximin is Pedigree AD54587_10 with an expiration date of 4/30/2014.
Consumers and healthcare providers should check their inventory for Rifaximin 200 mg tablets with the specified pedigree and expiration date. If the product is found, it should be returned to the distributor or the FDA should be contacted for further instructions.
The recalled product
- Product
- rifAXIMin Tablet, 200 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 65649030103
- Manufacturer
- Aidapak Services, LLC
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 30
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)
- rifAXIMin Tablet
- 200 mg has the following code Pedigree: AD54587_10
- EXP: 4/30/2014.
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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