The Recall Desk
ModerateFDA (Drugs)·D-665-2014·Announced 2014-01-22

Quetiapine Fumarate Tablets Recalled for Potential Labeling Mixup

Aidapak Services is recalling 1,300 Quetiapine Fumarate 100 mg tablets because they may be 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, which typically involves a temporary or medically reversible adverse health consequence. The hazard is a labeling mixup, which is a significant risk but does not involve a structural defect or reported fatalities.

Plain-English summary

Aidapak Services, LLC is recalling 1,300 tablets of Quetiapine Fumarate 100 mg (NDC 60505313301) due to a labeling mixup. The recalled product may be potentially mislabeled as Docusate Calcium 240 mg capsules, Nicotine Polacrilex 2 mg lozenges, or Docusate Sodium 250 mg capsules.

The affected Quetiapine Fumarate tablets have specific pedigree and expiration codes: Pedigree W002777 (EXP 6/6/2014), Pedigree W003825 (EXP 6/27/2014), and Pedigree AD73623_13 (EXP 5/30/2014). The repacked drugs were distributed in Arizona, California, Oregon, and Washington.

Consumers and healthcare providers should check their inventory for these specific pedigree and expiration codes. 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 about their medication.

The recalled product

Product
QUEtiapine FUMARATE Tablet, 100 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 60505313301
Affected units
1,300

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 (8)

  • QUEtiapine FUMARATE
  • Tablet
  • 100 mg has the following codes Pedigree: W002777
  • EXP: 6/6/2014
  • Pedigree: W003825
  • EXP: 6/27/2014
  • Pedigree: AD73623_13
  • EXP: 5/30/2014.

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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