Quetiapine Fumarate Tablets Recalled Due to Potential Labeling Mixup
Aidapak Services is recalling Quetiapine Fumarate 25 mg tablets because they may be mislabeled as multivitamin or aspirin products.
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 labeling error that could cause temporary or medically reversible health consequences. The rubric aligns minor labeling errors with a Moderate severity score.
Plain-English summary
Aidapak Services, LLC is recalling Quetiapine Fumarate, Tablet, 25 mg (NDC 60505313001) due to a labeling mixup. The recalled repacked drugs were distributed in Arizona, California, Oregon, and Washington.
The recall is necessary because the Quetiapine Fumarate tablets may be potentially mislabeled as MULTIVITAMIN/MULTIMINERAL, Chew Tablet (NDC 58914001460) or ASPIRIN DR EC, Tablet, 81 mg (NDC 00182106105). The affected Quetiapine Fumarate tablets have the following codes: Pedigree AD33897_25 with an expiration date of 5/9/2014, and Pedigree W003099 with an expiration date of 6/13/2014.
Consumers and healthcare providers should check their inventory for these specific NDCs and pedigree codes. If the products are found, they should be returned to the distributor or disposed of according to local regulations. Patients should consult their healthcare provider if they have questions regarding their medication.
The recalled product
- Product
- QUEtiapine FUMARATE, Tablet, 25 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 60505313001
- Manufacturer
- Aidapak Services, LLC
- Category
- Drug — Prescription Medication
- Hazard
- 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 (6)
- QUEtiapine FUMARATE
- Tablet
- 25 mg has the following codes Pedigree: AD33897_25
- EXP: 5/9/2014
- Pedigree: W003099
- EXP: 6/13/2014.
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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