The Recall Desk
ModerateFDA (Drugs)·D-907-2014·Announced 2014-01-29

Aidapak Recalls Albuterol Sulfate ER Tablets Due to Labeling Error

Aidapak Services, LLC is recalling Albuterol Sulfate ER 4 mg tablets that may have been mislabeled as Simvastatin 20 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 mixup without reported injuries or illnesses, fitting the criteria for moderate severity.

Plain-English summary

Aidapak Services, LLC is recalling Albuterol Sulfate ER, Tablet, 4 mg, NDC 00378412201, due to a labeling error. The recalled product may have been mislabeled as Simvastatin, Tablet, 20 mg, NDC 16714068303.

The affected product is identified by Pedigree W003578 and an expiration date of 6/24/2014. The repacked drugs were distributed in Arizona, California, Oregon, and Washington.

Consumers should check their medication for the specific NDC and pedigree codes listed above. If the product matches the description, they should contact their pharmacist or healthcare provider for guidance on proper disposal or replacement.

The recalled product

Product
ALBUTEROL SULFATE ER, Tablet, 4 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00378412201.
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)

  • ALBUTEROL SULFATE ER
  • Tablet
  • 4 mg has the following codes: Pedigree: W003578
  • EXP: 6/24/2014.

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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