Recalls / Class III
Class IIID-1570-2014
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
- Affected lot / code info
- Lot # KK6086, exp 03/2015, UPC 360505375998.
Why it was recalled
Failed Impurity/Degradation Specification; high out of specification for CAD II degradant
Recalling firm
- Firm
- Apotex Corp.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 2400 N Commerce Pkwy Ste 400, N/A, Weston, Florida 33326-3253
Distribution
- Quantity
- 1,494 bottles
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2014-08-21
- FDA classified
- 2014-09-15
- Posted by FDA
- 2014-09-24
- Terminated
- 2019-10-02
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1570-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.