Apotex Recalls Candesartan Cilexetil Tablets Due to Impurity Failures
Apotex Inc. is recalling specific lots of Candesartan Cilexetil Tablets because they failed impurity and degradation specifications.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The FDA classifies this as a Class III recall, which the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences.
Plain-English summary
Apotex Inc. is recalling Candesartan Cilexetil Tablets, 8 mg, 30-count bottles. The affected product is prescription-only and was manufactured by Apotex Research Pvt. Ltd. in India for Apotex Corp. in Florida. The recall involves 18,493 units distributed nationwide.
The recall was initiated because out-of-specification results were observed for CAD-II, CAD-V, and Total Impurities. The affected lots are KR3933 (expiration 10/15), KR3935, and KR3934 (expiration 11/15).
The U.S. Food and Drug Administration classifies this as a Class III recall, which indicates that the product is not likely to cause adverse health consequences. Consumers and healthcare providers should stop using the affected lots and contact their pharmacist or healthcare provider for guidance.
The recalled product
- Product
- Candesartan Cilexetil Tablets, 8 mg, 30-count bottle, Rx Only, Manufactured by Apotex Research Pvt. Ltd., Bangalore- 560 099, India, Manufactured for Apotex Corp., Weston, FL 33326, NDC 60505-3619-3
- Manufacturer
- Apotex Inc.
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 18,493
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 (4)
- Lot # KR3933
- Exp.10/15 Lot # KR3935
- KR3934
- Exp.11/15
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 4 recalled by Apotex Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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