Why it was recalled
Failed Impurity/Degradation Specification; high out of specification for CAD II degradant
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
Lot numbers, UPCs & expiration codes
Lot # KK6086, exp 03/2015, UPC 360505375998.
Where it was sold
Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1570-2014
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Aug 21, 2014
- FDA report date
- Sep 24, 2014
- Quantity
- 1,494 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Apotex Corp.
Original FDA data
Every field from FDA enforcement report D-1570-2014, exactly as published.
Show all FDA fields
- City
- Weston
- State
- FL
- Status
- Terminated
- Country
- United States
- Event ID
- 69170
- Address
- 2400 N Commerce Pkwy Ste 400
- Code information
- Lot # KK6086, exp 03/2015, UPC 360505375998.
- Postal code
- 33326-3253
- Report date
- Sep 24, 2014
- Product type
- Drugs
- Recall number
- D-1570-2014
- Classification
- Class III
- Recalling firm
- Apotex Corp.
- Product quantity
- 1,494 bottles
- Termination date
- Oct 2, 2019
- Reason for recall
- Failed Impurity/Degradation Specification; high out of specification for CAD II degradant
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- Nationwide
- Recall initiation date
- Aug 21, 2014
- Initial firm notification
- Letter
- Center classification date
- Sep 15, 2014