FDA Recalls Nefazodone Tablets Due to Potential Labeling Error
Aidapak Services is recalling Nefazodone HCL 150 mg tablets because they may have been mislabeled as Liothyronine Sodium 25 mcg.
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 illnesses or injuries, fitting the criteria for a moderate severity score.
Plain-English summary
Aidapak Services, LLC is recalling Nefazodone HCL, Tablet, 150 mg (NDC 00093711306) due to a potential labeling error. The recalled product may have been mislabeled as Liothyronine Sodium, Tablet, 25 mcg (NDC 42794001902). The specific pedigree for the recalled Nefazodone is AD46414_41, with an expiration date of 5/16/2014.
The repacked drugs were distributed in Arizona, California, Oregon, and Washington. The recall is classified as FDA Class II, indicating a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences.
Consumers who have this product should contact their healthcare provider or pharmacist for guidance. The source text does not report any illnesses or injuries associated with this recall.
The recalled product
- Product
- NEFAZODONE HCL, Tablet, 150 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00093711306.
- 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)
- NEFAZODONE HCL
- Tablet
- 150 mg has the following codes: Pedigree: AD46414_41
- EXP: 5/16/2014.
Distribution
Part of a larger recall action
This product is one of 265 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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