Recalls / Class III
Class IIID-0288-2015
Product
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
- Affected lot / code info
- Lot #: 3007330, Exp 11/2014
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.
Recalling firm
- Firm
- Sandoz, Inc
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 506 Carnegie Ctr Ste 400, N/A, Princeton, New Jersey 08540-6243
Distribution
- Quantity
- 6,336 bottles
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2014-10-02
- FDA classified
- 2014-12-02
- Posted by FDA
- 2014-12-10
- Terminated
- 2015-07-23
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0288-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.