Riluzole Tablets Recalled for Potential Labeling Mixup with Trazodone
Aidapak Services, LLC is recalling Riluzole 50 mg tablets due to a labeling error where they may be mislabeled as Trazodone HCl 150 mg.
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 error (mislabeling) without reported injuries or illnesses, fitting the criteria for moderate severity.
Plain-English summary
Aidapak Services, LLC is recalling Riluzole Tablet, 50 mg, NDC 64980019106, due to a labeling mixup. The recalled product may be potentially mislabeled as traZODone HCl, Tablet, 150 mg, NDC 50111044101.
The affected product is identified by Pedigree W003255 and an expiration date of 6/17/2014. The repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Consumers should check their medication for the specific NDC and pedigree codes listed above. If the product matches the description, they should contact their healthcare provider or pharmacist for guidance on proper disposal or replacement.
The recalled product
- Product
- RILUZOLE Tablet, 50 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 64980019106
- Manufacturer
- Aidapak Services, LLC
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 240
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)
- RILUZOLE Tablet
- 50 mg has the following code Pedigree: W003255
- EXP: 6/17/2014.
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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