Aripiprazole 20mg Tablets Recalled for Failed Dissolution
Apotex Corp. is recalling 2,010 bottles of Aripiprazole Tablets 20mg nationwide due to failed dissolution specifications. Tablets may not dissolve properly, potentially affecting medication effectiveness.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall with no reported illnesses or injuries. The hazard—failed dissolution preventing proper therapeutic dosing—represents a quality defect with potential for harm but no actual patient harm documented in the source text, meeting the criterion for a High severity rating.
Plain-English summary
Apotex Corp. is recalling 2,010 bottles of Aripiprazole Tablets, USP 20mg, distributed nationwide. The recall affects two lot numbers (TD9591 and TD9592, both expiring 04/2023) in both 30-count and 1,000-count bottles.
The recall was initiated because the tablets failed dissolution specifications at the 12-month stability time point. When tablets do not dissolve properly in the body, patients may not receive the full therapeutic dose of the medication.
Aripiprazole is a prescription antipsychotic medication used to treat schizophrenia and bipolar disorder. Patients currently taking this medication who have bottles from the affected lots should contact their pharmacy or healthcare provider for guidance.
Do not stop taking your medication without consulting your healthcare provider, as abrupt discontinuation could be harmful. Contact your pharmacy to exchange the affected product or discuss alternative options with your doctor.
The recalled product
- Product
- Aripiprazole Tablets, USP 20 mg, packaged in a) 1,000-count bottle (NDC 60505-2676-8, UPC 3 60505 26768 2), b) 30-count bottle (NDC 60505-2676-3, UPC 3 60505 26763 7), Rx only, Manufactured by: Apotex, Inc. Toronto, Ontario Canada M9L 1T9 Manufactured for: Apotex Corp. Weston, F
- Manufacturer
- Apotex Corp.
- Category
- Drug
- Hazard
- dissolution-failure
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 (2)
- Lots: a) TD9591 Exp. 04/2023
- b) TD9592 Exp. 04/2023
Distribution
Distributed nationwide across the United States.
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