The Recall Desk
ModerateFDA (Drugs)·D-834-2014·Announced 2014-01-29

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.

What this means for you

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.
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

Distributed in 4 states:

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.

See all 265 products in this recall →

Same manufacturer · Aidapak Services, LLC

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