Recalls / Class III
Class IIID-0659-2016
Product
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
- Affected lot / code info
- 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
Why it was recalled
Failed Impurities/Degradation Specifications; 9 month stability timepoint
Recalling firm
- Firm
- Sandoz Inc
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 100 College Rd W, N/A, Princeton, New Jersey 08540-6604
Distribution
- Quantity
- 277,267 bottles
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2015-12-31
- FDA classified
- 2016-02-11
- Posted by FDA
- 2016-02-17
- Terminated
- 2017-04-12
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0659-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.