Recalls / Class III
Class IIID-0660-2016
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)
- Affected lot / code info
- Lot # 153855, exp 01/2017
Why it was recalled
Failed Impurities/Degradation Specifications; 9 month stability (manufacturer)
Recalling firm
- Firm
- Amerisource Health Services
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 2550 John Glenn Ave, Suite A, Columbus, Ohio 43217-1188
Distribution
- Quantity
- 716 cartons
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2016-01-26
- FDA classified
- 2016-02-11
- Posted by FDA
- 2016-02-17
- Terminated
- 2017-01-11
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0660-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.