D-1570-2014 Class III Terminated
FDA drug recall D-1570-2014 was initiated by Apotex Corp. on Aug 21, 2014 and is designated Class III. Reason for recall: Failed Impurity/Degradation Specification; high out of specification for CAD II degradant The recall status is terminated (terminated Oct 2, 2019). Affected quantity: 1,494 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- Sep 24, 2014
- Initiation Date
- Aug 21, 2014
- Termination Date
- Oct 2, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,494 bottles
Product Description
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
Distribution Pattern
Nationwide
Code Information
Lot # KK6086, exp 03/2015, UPC 360505375998.
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-1570-2014
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026