The Recall Desk
ModerateFDA (Drugs)·D-951-2014·Announced 2014-01-29

Aidapak Recalls HydrOXYzine Pamoate Capsules Due to Labeling Mixup

Aidapak Services, LLC is recalling 100 mg HydrOXYzine Pamoate capsules because they may have been mislabeled as other medications.

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, but the source text describes a labeling mixup without reporting any illnesses or injuries, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

Aidapak Services, LLC is voluntarily recalling 800 capsules of HydrOXYzine Pamoate, 100 mg, NDC 00555032402. The recall was initiated because the medication may have been mislabeled as Calcium Citrate or Guaifenesin ER tablets.

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

Consumers should check their medication labels and contact their healthcare provider or pharmacist if they have questions about the recalled product.

The recalled product

Product
hydrOXYzine PAMOATE, Capsule, 100 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00555032402.
Affected units
800

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 (16)

  • hydrOXYzine PAMOATE
  • Capsule
  • 100 mg has the following codes: Pedigree: AD46265_28
  • EXP: 5/15/2014
  • Pedigree: W002735
  • EXP: 6/6/2014
  • Pedigree: W003690
  • EXP: 6/26/2014
  • Pedigree: AD21790_61
  • EXP: 5/1/2014
  • Pedigree: AD60272_67
  • EXP: 5/22/2014
  • Pedigree: W003008
  • EXP: 6/11/2014
  • Pedigree: W003332
  • EXP: 6/18/2014.

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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