Candesartan Cilexetil Tablets, USP, 4 mg, 30-count bottles, Rx only, Manufactured for…

Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.

Recalling firm

Macleods Pharma Usa Inc

NDC code

33342-114-10

Origin

NJ, United States

Initiated by

Voluntary: Firm initiated

FDA recall number

D-0329-2021

Other Candesartan recalls

See all

Class III · Low risk Terminated Sep 13, 2021

Candesartan Cilexetil Tablets, USP 16 mg, 30 count bottles, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505…

Reason Failed Impurities/Degradation Specifications; out of specification for Related Compound

Viatris NDC 0378-3231-93 D-0798-2021

Class III · Low risk Terminated Oct 2, 2020

Candesartan Cilexetil and Hydrochlorothiazide Tablets, USP 32 mg/12.5 mg, packaged in a) 90-count bottles (NDC 0378-3002-77) and…

Reason Out-of-specification organic impurity results obtained during routine stability testing.

Mylan Pharmaceuticals Inc. NDC 0378-3002-77 D-0049-2021

Class III · Low risk Terminated Jan 26, 2016

Candesartan Cilexetil Tablets, 16 mg, 30 Tablets (5 x 6) blister pack, Rx, Distributed by: American Health Packaging Columbus…

Reason Failed Impurities/Degradation Specifications; 9 month stability (manufacturer)

Amerisource Health Services NDC 68084-877-25 D-0660-2016

Class III · Low risk Terminated Dec 31, 2015

Candesartan Cilexetil Tablets, 16 mg, a) 30 count (NDC 00781-5938-31) and b) 90 count (NDC 00781-5938-92) bottles, Rx Only…

Reason Failed Impurities/Degradation Specifications; 9 month stability timepoint

Sandoz Inc NDC 00781-5938-31 D-0659-2016

Class III · Low risk Terminated Oct 16, 2014

Candesartan Cilexetil Tablets, 32 mg, a) 30-count bottle (NDC 60505-3621-3) b) 90-count bottles (NDC 60505-3621-9) Rx Only…

Reason Failed Impurities/Degradation Specifications: Out of specification (OOS) results were observed for CAD-II, CAD-V and Total Impurities.

Apotex Inc. NDC 60505-3621-3 D-0244-2015