The Recall Desk
ModerateFDA (Drugs)·D-814-2014·Announced 2014-01-29

Fluvastatin Sodium Capsules Recalled for Potential Labeling Error

Aidapak Services is recalling Fluvastatin Sodium 20 mg capsules because they may be mislabeled as Valsartan 80 mg 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 error (label mixup) with no reported illnesses or injuries, fitting the criteria for a moderate severity score.

Plain-English summary

Aidapak Services, LLC is recalling Fluvastatin Sodium, Capsule, 20 mg (NDC 00078017615). The recall is due to a labeling error where the product may have been mislabeled as Valsartan, Tablet, 80 mg (NDC 00078035834). The affected product has the pedigree AD73597_7 and an expiration date of 5/31/2014.

The repacked drugs were distributed in Arizona, California, Oregon, and Washington. The source text does not specify the number of units affected or report any illnesses or injuries.

Consumers should check their medication for the specific NDC and pedigree listed above. If the product matches the description, they should stop using it and contact their pharmacist or healthcare provider for guidance.

The recalled product

Product
FLUVASTATIN SODIUM, Capsule, 20 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00078017615.
Affected units
30

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)

  • FLUVASTATIN SODIUM
  • Capsule
  • 20 mg has the following codes: Pedigree: AD73597_7
  • EXP: 5/31/2014.

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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