Quetiapine Fumarate Tablets Recalled for Failed Dissolution Test
American Health Packaging is recalling Quetiapine Fumarate 25mg tablets because they failed a dissolution test during stability studies.
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 indicates a situation where use of the product might cause temporary or medically reversible health consequences. The hazard is a quality control failure (dissolution) rather than a direct safety event like contamination or injury.
Plain-English summary
American Health Packaging is recalling Quetiapine Fumarate Tablets, 25mg, NDC 68084-530-01. The recall involves 19,060 blister cards of the medication, which are distributed nationwide. The specific lot affected is 122600, with an expiration date of 03/14.
The recall was initiated because the tablets failed to meet dissolution test requirements. This failure was identified during the analysis of long-term stability studies at the 3-month time point, resulting in an out-of-specification (OOS) report.
Consumers and healthcare providers should stop using the affected medication and return it to the pharmacy or point of purchase for a refund or replacement. Patients should consult their healthcare provider for alternative treatment options if necessary.
The recalled product
- Product
- QUETIAPINE Fumarate Tablets 25mg 100 Tablets (10x10) Blister card, Rx, Packaged and Distributed by: American Health Packaging, Columbus, Ohio 43217, NDC 68084-530-01
- Manufacturer
- American Health Packaging
- Category
- Drug — Prescription Medication
- Affected units
- 19,060
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 (1)
- Lot 122600 Exp. 03/14
Distribution
Distributed nationwide across the United States.
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