Lurasidone HCl Tablets Recalled for Potential Labeling Mixup
Aidapak Services is recalling Lurasidone HCl 120 mg tablets because they may be mislabeled as Duloxetine HCl DR 20 mg capsules.
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. Per the rubric, minor labeling errors and voluntary precautionary recalls are typically rated as Moderate (2).
Plain-English summary
Aidapak Services, LLC is recalling Lurasidone HCl tablets, 120 mg, NDC 63402031230. The recall is due to a labeling mixup where the product may be mislabeled as Duloxetine HCl DR capsules, 20 mg, NDC 00002323560.
The affected Lurasidone HCl tablets have the pedigree W003487 and an expiration date of 6/20/2014. The repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Consumers should check their medication for the specific NDC and pedigree listed above. If the product matches the description, they should stop using it and contact their pharmacist or healthcare provider for guidance.
The recalled product
- Product
- LURASIDONE HCL, Tablet, 120 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 63402031230
- Manufacturer
- Aidapak Services, LLC
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 60
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 (4)
- LURASIDONE HCL
- Tablet
- 120 mg has the following code Pedigree: W003487
- EXP: 6/20/2014.
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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