The Recall Desk
SevereFDA (Drugs)·D-861-2014·Announced 2014-01-29

Aidapak Recalls Digoxin Tablets Due to Potential Label Mixup

Aidapak Services is recalling Digoxin tablets because they may have been mislabeled as other medications. The repacked drugs were distributed in four western states.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The FDA classified this recall as Class II. According to the rubric, an FDA Class II recall with potential for adverse health consequences (such as receiving the wrong medication) corresponds to a severity score of 4 (Severe), particularly given the critical nature of the drugs involved.

Plain-English summary

Aidapak Services, LLC is recalling Digoxin, Tablet, 0.125 mg, because the medication may have been mislabeled as other drugs. The recall involves repacked drugs distributed in Arizona, California, Oregon, and Washington. The specific products affected include four distinct pedigree codes with expiration dates ranging from April 30, 2014, to June 13, 2014.

The source text indicates that the Digoxin tablets may have been mislabeled as Melatonin, Desmopressin Acetate, Propranolol HCl, or Liothyronine Sodium. This labeling error creates a risk that patients may receive the wrong medication. The FDA has classified this recall as Class II, indicating that use of or exposure to the product might cause temporary or medically reversible adverse health consequences.

Consumers and healthcare providers should check their inventory for Digoxin tablets with the specific pedigree codes listed in the recall notice. If the product is found, it should be returned to the distributor or the recalling firm, Aidapak Services, LLC. Patients should consult their healthcare provider if they have questions about their medication.

The recalled product

Product
DIGOXIN, Tablet, 0.125 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00115981101.
Affected units
400

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 (10)

  • DIGOXIN
  • Tablet
  • 0.125 mg has the following codes: Pedigree: AD22609_4
  • EXP: 4/30/2014
  • Pedigree: AD46426_22
  • EXP: 5/15/2014
  • Pedigree: AD62829_8
  • EXP: 5/23/2014
  • Pedigree: W003154
  • EXP: 6/13/2014.

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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