Sotalol HCL Tablets Recalled for Potential Labeling Mixup
Aidapak Services, LLC is recalling Sotalol HCL 160 mg tablets that may have been mislabeled as Disulfiram 250 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 a moderate severity score.
Plain-English summary
Aidapak Services, LLC is recalling Sotalol HCL, Tablet, 160 mg, NDC 00093106201, due to a potential labeling mixup. The recalled product may have been mislabeled as Disulfiram, Tablet, 250 mg, NDC 64980017101.
The affected Sotalol HCL tablets have the pedigree AD22609_10 and an expiration date of 4/30/2014. 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 contact their healthcare provider or pharmacist for guidance on proper disposal or replacement.
The recalled product
- Product
- SOTALOL HCL, Tablet, 160 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00093106201.
- Manufacturer
- Aidapak Services, LLC
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 101
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)
- SOTALOL HCL
- Tablet
- 160 mg has the following codes: Pedigree: AD22609_10
- EXP: 4/30/2014.
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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