Class III · Low risk
Candesartan Cilexetil Tablets
Failed Impurities/Degradation Specifications; out of specification for Related Compound
Candesartan Cilexetil Tablets
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Failed Impurities/Degradation Specifications; 9 month stability (manufacturer)
Cause type: Impurity / degradation
An impurity or degradation product above its limit - other than nitrosamines. Unexpected substances in a batch can make it unsafe or less effective, even when the active ingredient is present. All impurity / degradation recalls.
What was recalled
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)
Affected NDCs
68084-0877-25
68084-0877-95
Compare with the code on your package — it is the most precise check available.
Drug: Candesartan Category: Blood Pressure Medication
- Recalling firm
- Amerisource Health Services
- NDC code
- 68084-877-25
- Origin
- OH, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0660-2016 · FDA notice
Low risk, still worth a check. Class III means the product is unlikely to cause harm but breaks an FDA rule (often labeling). If your lot matches, your pharmacy will normally swap it; there is no need for alarm. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Candesartan recalls
See all
Class III · Low risk
Candesartan Cilexetil Tablets
Failed Impurities/Degradation Specifications
Class III · Low risk
Candesartan Cilexetil and Hydrochlorothiazide Tablets
Out-of-specification organic impurity results obtained during routine stability testing.
Class III · Low risk
Candesartan Cilexetil Tablets
Failed Impurities/Degradation Specifications; 9 month stability timepoint
Class III · Low risk
Candesartan Cilexetil Tablets
Failed Impurities/Degradation Specifications: Out of specification (OOS) results were observed for CAD-II, CAD-V and Total Impurities.
Other recalls by Amerisource Health Services
All 2016 recalls
Class III · Low risk
Primidone Tablets
Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.
Class III · Low risk
Primidone Tablets
Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.
Class II · Moderate risk
Meclizine Hydrochloride Tablets
Failed tablet specifications.
Class II · Moderate risk
Oxycodone Hydrochloride Tablets
Defective container: card seal defects (weak/non-existent seals), leading to the tablets falling out of their cavities.
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