The Recall Desk
ModerateFDA (Drugs)·D-590-2014·Announced 2014-01-22

Aidapak Recalls Hydralazine HCL Tablets Due to Potential Label Mixup

Aidapak Services, LLC is recalling Hydralazine HCL 25 mg tablets because they may be mislabeled as Docusate Calcium 240 mg capsules.

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) without reported injuries or illnesses, fitting the criteria for a moderate severity score.

Plain-English summary

Aidapak Services, LLC is recalling Hydralazine HCL 25 mg tablets (NDC 50111032701) due to a potential labeling error. The source text indicates that the Hydralazine HCL tablets may be mislabeled as Docusate Calcium 240 mg capsules (NDC 00536375501).

The affected product is identified by the pedigree AD49610_4 and an expiration date of 5/16/2014. The repacked drugs were distributed in Arizona, California, Oregon, and Washington.

Consumers and healthcare providers should check their inventory for Hydralazine HCL 25 mg tablets with the specified pedigree and expiration date. If found, these products should be quarantined and returned to the distributor or manufacturer for further instructions.

The recalled product

Product
HYDRALAZINE HCL Tablet, 25 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 50111032701
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)

  • HYDRALAZINE HCL
  • Tablet
  • 25 mg has the following code Pedigree: AD49610_4
  • EXP: 5/16/2014.

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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