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.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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
- Manufacturer
- Aidapak Services, LLC
- Category
- Drug — Prescription Medication
- Hazard
- 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
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.
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