The Recall Desk
ModerateFDA (Drugs)·D-838-2014·Announced 2014-01-29

FDA Recalls Bumetanide Tablets Due to Potential Labeling Error

Aidapak Services, LLC is recalling Bumetanide 1 mg tablets that may have been mislabeled as Guaifenesin ER 600 mg. The error could lead to incorrect medication administration.

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 typically involves a temporary or medically reversible adverse health consequence. The hazard is a labeling error that could lead to incorrect medication use, but no specific injuries or illnesses are reported in the source text.

Plain-English summary

Aidapak Services, LLC is voluntarily recalling Bumetanide, Tablet, 1 mg (NDC 00093423301) due to a potential labeling error. The recalled product, which contains 100 tablets per bottle, may have been mislabeled as Guaifenesin ER, Tablet, 600 mg (NDC 63824000815). Both products share the same expiration date of June 17, 2014, but have different pedigree codes (W003224 for Bumetanide and W003218 for Guaifenesin ER).

The mislabeled Bumetanide tablets were distributed in Arizona, California, Oregon, and Washington. This labeling mixup poses a risk of patients or healthcare providers administering the wrong medication, which could result in therapeutic failure or adverse effects depending on the patient's condition.

Patients and healthcare providers should check their Bumetanide 1 mg tablets for the NDC 00093423301 and pedigree W003224. If the product matches these identifiers, it should be returned to the pharmacy or healthcare provider for replacement or refund. Consumers should not take the medication if they suspect it is mislabeled and should consult their healthcare provider for appropriate treatment.

The recalled product

Product
BUMETANIDE, Tablet, 1 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00093423301.
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 (4)

  • BUMETANIDE
  • Tablet
  • 1 mg has the following codes: Pedigree: W003224
  • EXP: 6/17/2014.

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 →