Why it was recalled
Failed Impurities/Degradation Specifications: An Out of Specification (OOS) result was generated for the 18 month stability time point for ketone cilexetil impurity and total impurities.
Product description
candesartan cilexetil, tablets, 16 mg, 90-count bottles, Rx only, Manufactured for Sandoz Inc., Princeton, NJ 08540 by Mylan Laboratories Limited Hyderabad, 500 034, India, NDC 0781-5938-92
Lot numbers, UPCs & expiration codes
Lot #: 3007330, Exp 11/2014
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-0288-2015
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Oct 2, 2014
- FDA report date
- Dec 10, 2014
- Quantity
- 6,336 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Sandoz, Inc
Original FDA data
Every field from FDA enforcement report D-0288-2015, exactly as published.
Show all FDA fields
- City
- Princeton
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 69688
- Address
- 506 Carnegie Ctr Ste 400
- Code information
- Lot #: 3007330, Exp 11/2014
- Postal code
- 08540-6243
- Report date
- Dec 10, 2014
- Product type
- Drugs
- Recall number
- D-0288-2015
- Classification
- Class III
- Recalling firm
- Sandoz, Inc
- Product quantity
- 6,336 bottles
- Termination date
- Jul 23, 2015
- Reason for recall
- Failed Impurities/Degradation Specifications: An Out of Specification (OOS) result was generated for the 18 month stability time point for ketone cilexetil impurity and total impurities.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- candesartan cilexetil, tablets, 16 mg, 90-count bottles, Rx only, Manufactured for Sandoz Inc., Princeton, NJ 08540 by Mylan Laboratories Limited Hyderabad, 500 034, India, NDC 0781-5938-92
- Distribution pattern
- Nationwide
- Recall initiation date
- Oct 2, 2014
- Initial firm notification
- Letter
- Center classification date
- Dec 2, 2014