The Recall Desk
ModerateFDA (Drugs)·D-833-2014·Announced 2014-01-29

Aidapak Recalls Sotalol HCL Tablets Due to Potential Labeling Errors

Aidapak Services, LLC is recalling Sotalol HCL 80 mg tablets because they may have been mislabeled as Diltiazem HCL or Propranolol HCL ER.

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, which corresponds to a moderate severity score for a labeling error that could lead to incorrect medication administration but is not associated with reported serious injury or death.

Plain-English summary

Aidapak Services, LLC is recalling Sotalol HCL, Tablet, 80 mg, NDC 00093106101. The recall is due to a labeling error where the product may have been mislabeled as Diltiazem HCL, Tablet, 120 mg, or Propranolol HCL ER, Capsule, 60 mg.

The affected Sotalol HCL tablets have the following pedigree and expiration codes: Pedigree AD30993_17, EXP 5/9/2014; and Pedigree AD52778_85, EXP 5/21/2014. The repacked drugs were distributed in Arizona, California, Oregon, and Washington.

Consumers and healthcare providers should check their inventory for these specific pedigree and expiration codes. If the product matches the recalled description, it should be returned to the distributor or disposed of according to local regulations.

The recalled product

Product
SOTALOL HCL, Tablet, 80 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00093106101.
Affected units
202

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 (6)

  • SOTALOL HCL
  • Tablet
  • 80 mg has the following codes: Pedigree: AD30993_17
  • EXP: 5/9/2014
  • Pedigree: AD52778_85
  • EXP: 5/21/2014.

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

See all →