Candesartan Cilexetil and Hydrochlorothiazide Tablets 32 mg/12.5 mg, 90 count bottles, Rx only, Manufactured by: Apotex Research Pvt. Ltd. Bangalore - 560 099, India NDC 60505-3759-9

FDA recall notice · announced September 24, 2014 · Apotex

Class III FDA/FSIS Class III: use is not likely to cause adverse health consequences.

The product

Candesartan Cilexetil and Hydrochlorothiazide Tablets 32 mg/12.5 mg, 90 count bottles, Rx only, Manufactured by: Apotex Research Pvt. Ltd. Bangalore - 560 099, India NDC 60505-3759-9

Reason for recall

Failed Impurity/Degradation Specification; high out of specification for CAD II degradant

Notes

Distribution: Nationwide
Lot/code information: Lot # KK6086, exp 03/2015, UPC 360505375998.
Quantity: 1,494 bottles
Status: Terminated
Products in this recall event:
- Candesartan Cilexetil and Hydrochlorothiazide Tablets 32 mg/12.5 mg, 90 count bottles, Rx only, Manufactured by: Apotex Research Pvt. Ltd. Bangalore - 560 099, India NDC 60505-3759-9 (D-1570-2014)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.