The Recall Desk
ModerateFDA (Drugs)·D-817-2014·Announced 2014-01-29

Valsartan 320 mg Tablets Recalled for Potential Labeling Error

Aidapak Services is recalling Valsartan 320 mg tablets because they may have been mislabeled as Cilostazol 100 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, which typically involves minor labeling errors or low-risk contamination where the probability of serious adverse health consequences is remote.

Plain-English summary

Aidapak Services, LLC is recalling Valsartan, Tablet, 320 mg (NDC 00078036034) due to a potential labeling error. The recall is initiated because the product may have been mislabeled as Cilostazol, Tablet, 100 mg (NDC 60505252201).

The affected product is identified by Pedigree AD65475_7 and an expiration date of 5/28/2014. The repacked drugs were distributed in Arizona, California, Oregon, and Washington.

Consumers and healthcare providers should check their inventory for Valsartan 320 mg tablets with the specified pedigree and expiration date. If found, the product should be returned to the distributor or pharmacy for replacement or refund. Patients should consult their healthcare provider if they have questions regarding their medication.

The recalled product

Product
VALSARTAN, Tablet, 320 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00078036034.
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)

  • VALSARTAN
  • Tablet
  • 320 mg has the following codes: Pedigree: AD65475_7
  • EXP: 5/28/2014.

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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