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
Reported: September 24, 2014 Initiated: August 21, 2014 #D-1570-2014
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
Details
- Recalling Firm
- Apotex Corp.
- Units Affected
- 1,494 bottles
- Distribution
- Nationwide
- Location
- Weston, FL
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Apotex Corp.. Units affected: 1,494 bottles.
Why was this product recalled? ▼
Failed Impurity/Degradation Specification; high out of specification for CAD II degradant
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on September 24, 2014. Severity: Low. Recall number: D-1570-2014.
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