The Recall Desk
ModerateFDA (Drugs)·D-837-2014·Announced 2014-01-29

Aidapak Recalls Bumetanide Tablets Due to Potential Label Mixup

Aidapak Services, LLC is recalling Bumetanide 0.5 mg tablets because they may have been mislabeled as Erythromycin DR EC 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 (label mixup) without reported illnesses or injuries, fitting the criteria for a moderate severity score.

Plain-English summary

Aidapak Services, LLC is recalling Bumetanide, Tablet, 0.5 mg, Rx only (NDC 00093423201) due to a potential labeling error. The recall is initiated because the Bumetanide tablets may have been mislabeled as Erythromycin DR EC, Tablet, 250 mg (NDC 24338012213).

The affected Bumetanide tablets have the pedigree AD46426_25 and an expiration date of 5/15/2014. The potentially mislabeled Erythromycin DR EC tablets have the pedigree AD46426_13 and an expiration date of 5/15/2014. The repacked drugs were distributed in Arizona, California, Oregon, and Washington.

Consumers and healthcare providers should check their Bumetanide 0.5 mg tablets for the pedigree AD46426_25 and expiration date 5/15/2014. If the product matches these details, it should be returned to the pharmacy or distributor for replacement or refund.

The recalled product

Product
BUMETANIDE, Tablet, 0.5 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00093423201.
Affected units
100

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 (5)

  • BUMETANIDE
  • Tablet
  • 0.5 mg
  • Rx only has the following codes: Pedigree: AD46426_25
  • EXP: 5/15/2014.

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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