Amerisource Recalls Candesartan Cilexetil Tablets Due to Impurity Failures
Amerisource Health Services is recalling 716 cartons of Candesartan Cilexetil Tablets, 16 mg, due to failed impurities 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 recall is classified as FDA Class III, which by definition is unlikely to cause adverse health consequences, fitting the Low severity criteria for documentation or minor specification issues.
Plain-English summary
Amerisource Health Services is recalling 716 cartons of Candesartan Cilexetil Tablets, 16 mg, 30 Tablets (5 x 6) blister pack. The product is distributed by American Health Packaging in Columbus, Ohio, and is identified by NDC 68084-877-25 (carton) and NDC 68084-877-95 (individual dose). The specific lot affected is # 153855, with an expiration date of 01/2017.
The recall was initiated because the product failed impurities and degradation specifications, as well as 9-month stability requirements. This is a manufacturer-initiated recall classified as Class III by the U.S. Food and Drug Administration.
The affected product was distributed nationwide. Consumers and healthcare providers should stop using the recalled medication and contact their pharmacist or healthcare provider for a replacement or alternative treatment. The recall is limited to the specific lot number and expiration date listed above.
The recalled product
- Product
- Candesartan Cilexetil Tablets, 16 mg, 30 Tablets (5 x 6) blister pack, Rx, Distributed by: American Health Packaging Columbus, Ohio 43217, NDC 68084-877-25(carton), NDC 68084-877-95(individual dose)
- Manufacturer
- Amerisource Health Services
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 716
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 # 153855
- exp 01/2017
Distribution
Distributed nationwide across the United States.
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