Why it was recalled
Failed Impurities/Degradation Specifications; 9 month stability timepoint
Product description
Candesartan Cilexetil Tablets, 16 mg, a) 30 count (NDC 00781-5938-31) and b) 90 count (NDC 00781-5938-92) bottles, Rx Only, Manufactured by Mylan Laboratories Limited Hyderabad 500 034, India for Sandoz Inc. Princeton, NJ 08540
Lot numbers, UPCs & expiration codes
a) 3022288 12/2015 3025988 03/2016 3025989 04/2016 3030459 08/2016 3030460 08/2016 3032087 10/2016 3032088 10/2016 3034506 12/2016 3035952 01/2017 3035953 01/2017 b) 3022287 12/2015 3025990 04/2016 3030458 08/2016 3032086 09/2016 3035954 01/2017
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-0659-2016
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Dec 31, 2015
- FDA report date
- Feb 17, 2016
- Quantity
- 277,267 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Sandoz Inc
Original FDA data
Every field from FDA enforcement report D-0659-2016, exactly as published.
Show all FDA fields
- City
- Princeton
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 73035
- Address
- 100 College Rd W
- Code information
- a) 3022288 12/2015 3025988 03/2016 3025989 04/2016 3030459 08/2016 3030460 08/2016 3032087 10/2016 3032088 10/2016 3034506 12/2016 3035952 01/2017 3035953 01/2017 b) 3022287 12/2015 3025990 04/2016 3030458 08/2016 3032086 09/2016 3035954 01/2017
- Postal code
- 08540-6604
- Report date
- Feb 17, 2016
- Product type
- Drugs
- Recall number
- D-0659-2016
- Classification
- Class III
- Recalling firm
- Sandoz Inc
- Product quantity
- 277,267 bottles
- Termination date
- Apr 12, 2017
- Reason for recall
- Failed Impurities/Degradation Specifications; 9 month stability timepoint
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Candesartan Cilexetil Tablets, 16 mg, a) 30 count (NDC 00781-5938-31) and b) 90 count (NDC 00781-5938-92) bottles, Rx Only, Manufactured by Mylan Laboratories Limited Hyderabad 500 034, India for Sandoz Inc. Princeton, NJ 08540
- Distribution pattern
- Nationwide
- Recall initiation date
- Dec 31, 2015
- Initial firm notification
- Letter
- Center classification date
- Feb 11, 2016