Apotex Recalls Candesartan Cilexetil Tablets Due to Impurity Failures
Apotex Inc. is recalling Candesartan Cilexetil Tablets, 16 mg, because out-of-specification results were observed for specific impurities and total impurities.
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 classified 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, 16 mg, in 30-count and 90-count bottles. The recall affects 11,062 bottles distributed nationwide. The specific lots involved are KR3943 (expiring 11/15) and KT6058 and KT6060 (expiring 11/15).
The recall was initiated because out-of-specification (OOS) results were observed for CAD-II, CAD-V, and Total Impurities. The FDA has classified this recall as Class III, which indicates that the product is not likely to cause adverse health consequences.
Consumers should stop using the recalled medication and consult their healthcare provider for further instructions. The product was manufactured by Apotex Research Pvt. Ltd. in India for Apotex Corp. in Florida.
The recalled product
- Product
- Candesartan Cilexetil Tablets, 16 mg, a) 30-count bottle (NDC 60505-3620-3) b) 90-count bottles (NDC 60505-3620-9) Rx Only, Manufactured by Apotex Research Pvt. Ltd., Bangalore- 560 099, India, Manufactured for Apotex Corp., Weston, FL 33326
- Manufacturer
- Apotex Inc.
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 11,062
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 #: a) KR3943
- Exp. 11/15 Lot #: b) KT6058
- KT6060
- Exp. Date 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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