The Recall Desk
ModerateFDA (Drugs)·D-726-2014·Announced 2014-01-22

Aidapak Recalls Amlodipine Tablets Due to Potential Labeling Error

Aidapak Services, LLC is recalling 10 mg amlodipine besylate tablets that may be mislabeled as 5 mg finasteride tablets.

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 between two different prescription medications. This fits the rubric for moderate severity involving labeling errors without reported injuries.

Plain-English summary

Aidapak Services, LLC is recalling 90-count bottles of amlodipine besylate tablets, 10 mg, NDC 68382012316. The recall is due to a labeling mixup where the product may be mislabeled as finasteride tablets, 5 mg, NDC 16714052201.

The affected amlodipine tablets have the pedigree AD62846_4 and an expiration date of 5/24/2014. The potentially mislabeled finasteride tablets have the pedigree AD62846_1 and an expiration date of 2/28/2014. The repacked drugs were distributed in Arizona, California, Oregon, and Washington.

Consumers who have this product should contact their healthcare provider or pharmacist for guidance on whether to continue taking the medication or to obtain a replacement.

The recalled product

Product
amLODIPine BESYLATE, Tablet, 10 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 68382012316
Affected units
90

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)

  • amLODIPine BESYLATE
  • Tablet
  • 10 mg has the following code Pedigree: AD62846_4
  • EXP: 5/24/2014.

Distribution

Distributed in 4 states:

Part of a larger recall action

This product is one of 273 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 273 products in this recall →

Same manufacturer · Aidapak Services, LLC

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