FDA Recalls Sotalol HCL Tablets Due to Potential Label Mixup
Aidapak Services, LLC is recalling Sotalol HCL 120 mg tablets because they may have been mislabeled as Neomycin Sulfate 500 mg tablets.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II, which corresponds to a Severe severity score (4) according to the rubric, as it involves a labeling error that could lead to the administration of the wrong medication.
Plain-English summary
Aidapak Services, LLC is recalling Sotalol HCL, Tablet, 120 mg (NDC 00093106001) due to a potential label mixup. The recalled product may have been mislabeled as Neomycin Sulfate, Tablet, 500 mg (NDC 51991073801).
The affected Sotalol HCL tablets have the pedigree AD49448_20 and an expiration date of 5/17/2014. The repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Consumers should check their medication for the specific pedigree and expiration date listed above. If the product matches the description, they should stop using it and contact their healthcare provider or pharmacist for instructions on how to dispose of the medication or obtain a replacement.
The recalled product
- Product
- SOTALOL HCL, Tablet, 120 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00093106001.
- 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 (3)
- SOTALOL HCL
- Tablet
- 120 mg has the following codes: Pedigree: AD49448_20 EXP: 5/17/2014.
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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