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.
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 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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