The Recall Desk
ModerateFDA (Drugs)·D-587-2014·Announced 2014-01-22

Doxepin HCL Capsules Recalled for Potential Label Mixup

Aidapak Services is recalling Doxepin HCL capsules due to a labeling error where they may be mislabeled as Valsartan 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) without reported injuries or illnesses, fitting the criteria for moderate severity.

Plain-English summary

Aidapak Services, LLC is recalling Doxepin HCL Capsules, 150 mg, NDC 49884022201, due to a labeling error. The product may be potentially mislabeled as Valsartan, Tablet, 160 mg, NDC 00078035934.

The recalled Doxepin HCL capsules have the pedigree AD46312_10 and an expiration date of 5/16/2014. The repacked drugs were distributed in Arizona, California, Oregon, and Washington.

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 healthcare provider or pharmacist for guidance.

The recalled product

Product
DOXEPIN HCL Capsule, 150 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 49884022201
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)

  • DOXEPIN HCL
  • Capsule
  • 150 mg has the following code Pedigree: AD46312_10
  • 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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