Why it was recalled
Failed Impurities/Degradation Specifications: Out of specification (OOS) results were observed for CAD-II, CAD-V and Total Impurities.
Product description
Candesartan Cilexetil Tablets, 16 mg, a) 30-count bottle (NDC 60505-3620-3) b) 90-count bottles (NDC 60505-3620-9) Rx Only, Manufactured by Apotex Research Pvt. Ltd., Bangalore- 560 099, India, Manufactured for Apotex Corp., Weston, FL 33326
Lot numbers, UPCs & expiration codes
Lot #: a) KR3943; Exp. 11/15 Lot #: b) KT6058, KT6060; Exp. Date 11/15
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-0243-2015
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Oct 16, 2014
- FDA report date
- Nov 12, 2014
- Quantity
- 11,062 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Apotex Inc.
Original FDA data
Every field from FDA enforcement report D-0243-2015, exactly as published.
Show all FDA fields
- City
- Toronto
- Status
- Terminated
- Country
- Canada
- Event ID
- 69546
- Address
- 150 Signet Drive
- Code information
- Lot #: a) KR3943; Exp. 11/15 Lot #: b) KT6058, KT6060; Exp. Date 11/15
- Report date
- Nov 12, 2014
- Product type
- Drugs
- Recall number
- D-0243-2015
- Classification
- Class III
- Recalling firm
- Apotex Inc.
- Product quantity
- 11,062 bottles
- Termination date
- Sep 30, 2016
- Reason for recall
- Failed Impurities/Degradation Specifications: Out of specification (OOS) results were observed for CAD-II, CAD-V and Total Impurities.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Candesartan Cilexetil Tablets, 16 mg, a) 30-count bottle (NDC 60505-3620-3) b) 90-count bottles (NDC 60505-3620-9) Rx Only, Manufactured by Apotex Research Pvt. Ltd., Bangalore- 560 099, India, Manufactured for Apotex Corp., Weston, FL 33326
- Distribution pattern
- Nationwide.
- Recall initiation date
- Oct 16, 2014
- Initial firm notification
- Letter
- Center classification date
- Nov 6, 2014