The Recall Desk
ModerateFDA (Drugs)·D-716-2014·Announced 2014-01-22

Aidapak Recalls Quetiapine Fumarate Tablets Due to Labeling Error

Aidapak Services, LLC is recalling Quetiapine Fumarate 25 mg tablets because they may be mislabeled as Chlordiazepoxide HCl 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 due to a labeling mixup. Per the rubric, minor labeling errors and voluntary precautionary recalls without reported injuries fall under the Moderate severity category.

Plain-English summary

Aidapak Services, LLC is voluntarily recalling Quetiapine Fumarate, Tablet, 25 mg, NDC 65862048901. The recall is due to a labeling error where the product may be mislabeled as Chlordiazepoxide HCl, Capsule, 25 mg, NDC 00555015902.

The affected product is identified by Pedigree AD49582_22 and an expiration date of 4/30/2014. The repacked drugs were distributed in Arizona, California, Oregon, and Washington.

Consumers and healthcare providers should stop using the affected product and contact their pharmacist or healthcare provider for guidance. The FDA has classified this recall as Class II, indicating a reasonable probability of temporary or medically reversible adverse health consequences.

The recalled product

Product
QUEtiapine FUMARATE, Tablet, 25 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 65862048901
Affected units
400

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)

  • QUEtiapine FUMARATE
  • Tablet
  • 25 mg has the following code Pedigree: AD49582_22
  • EXP: 4/30/2014.

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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