Irbesartan Blood Pressure Tablets Recalled Due to Failed Dissolution
Jubilant Cadista is recalling 9,600 bottles of Irbesartan Tablets (150mg) nationwide due to failed dissolution specifications. Affected lot IB220023A expires 08/2022.
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 without reported illnesses or injuries. Dissolution failure in a blood pressure medication creates risk of inadequate treatment, meeting the Score 3 criterion for risk-of-harm products where no injury has been reported.
Plain-English summary
Jubilant Cadista Pharmaceuticals, Inc. is recalling Irbesartan Tablets, USP, 150mg. A total of 9,600 bottles of the product were distributed nationwide in the United States. The recalled medication is Lot IB220023A with expiration date 08/2022.
The recall was initiated due to failed dissolution specifications. Dissolution testing verifies that tablets break down and release their active ingredient properly. Failure to meet these specifications means the tablets may not dissolve as intended.
Patients who are taking Irbesartan from the affected lot should not stop taking their medication without medical guidance. Instead, they should contact their pharmacist or healthcare provider to discuss whether their supply is affected and what steps to take next. Patients with the affected lot number should return the medication to their pharmacy for replacement or refund.
The recalled product
- Product
- IRBESARTAN (IRBESARTAN)
- Brand
- IRBESARTAN
- Manufacturer
- Jubilant Cadista Pharmaceuticals, Inc.
- 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 #: IB220023A
- exp. date 08/2022
UPCs (3)
- 0359746447304
- 0359746448301
- 0359746449308
Distribution
Distributed nationwide across the United States.
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