The Recall Desk
ModerateFDA (Drugs)·D-819-2014·Announced 2014-01-29

Valsartan 40 mg Tablets Recalled for Potential Labeling Errors

Aidapak Services is recalling Valsartan 40 mg tablets because they may have been mislabeled as Valsartan 80 mg or Zinc Sulfate 50 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 error (mislabeling) without reported illnesses or injuries, fitting the criteria for a moderate severity score.

Plain-English summary

Aidapak Services, LLC is recalling Valsartan 40 mg tablets (NDC 00078042315) due to a labeling error. The product may have been mislabeled as Valsartan 80 mg (NDC 00078035834) or Zinc Sulfate 50 mg (NDC 00904533260). The recalled Valsartan 40 mg tablets are identified by pedigree AD52372_1 (expiration 5/17/2014) and AD32579_1 (expiration 5/9/2014).

The repacked drugs were distributed in Arizona, California, Oregon, and Washington. This recall is classified as FDA Class II, indicating a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.

Consumers and healthcare providers should check their inventory for the specific NDC and pedigree codes listed above. If the product is found, it should be returned to the distributor or disposed of according to local regulations. Patients should consult their healthcare provider if they have questions regarding their medication.

The recalled product

Product
VALSARTAN, Tablet, 40 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00078042315.
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 (6)

  • VALSARTAN
  • Tablet
  • 40 mg has the following codes: Pedigree: AD52372_1
  • EXP: 5/17/2014
  • Pedigree: AD32579_1
  • EXP: 5/9/2014.

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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