Irbesartan Tablets Recalled Due to Out-of-Specification Dissolution
AvKARE is recalling Irbesartan Tablets USP 300 mg due to dissolution failure, affecting 341 cartons distributed nationwide. Patients should contact their pharmacist or doctor regarding their medication.
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. Dissolution failure on an essential blood pressure medication represents a risk-of-harm product where injury has not yet been reported, meeting the Score 3 criterion.
Plain-English summary
AvKARE is recalling Irbesartan Tablets USP, 300 mg, 50 Tablets per carton (Unit Dose packaging) with Lot 45279 and expiration date of March 31, 2025. The recall affects 341 cartons that were distributed nationwide in the United States.
The tablets are being recalled because they failed to meet United States Pharmacopeia (USP) dissolution specifications. Dissolution is the rate at which a medication dissolves in the body, and when this specification is not met, the active ingredient may not be properly absorbed, potentially reducing the medication's effectiveness.
Consumers who have received this product should contact their pharmacist or healthcare provider to determine if they have the affected lot. Patients should not discontinue their blood pressure medication without speaking with their healthcare provider first, as stopping blood pressure medication abruptly can be unsafe. Patients with this lot should return it to their pharmacy for proper handling.
The recalled product
- Product
- IRBESARTAN (IRBESARTAN)
- Brand
- IRBESARTAN
- Manufacturer
- AvKARE
- 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)
- Lot 45279
- Exp 03/31/2025
Distribution
Distributed nationwide across the United States.
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