Reported Dec 10, 2014 · Terminated
candesartan cilexetil, tablets, 16 mg, 90-count bottles, Rx only, Manufactured for Sandoz Inc., Princeton, NJ 08540 by…
Sandoz, Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Sandoz, Inc · 506 Carnegie Ctr Ste 400 · Princeton, NJ · 08540-6243
Is this the product you have?
- 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 codes and dates
Lot #: 3007330Exp 11/2014
- Amount recalled
- 6,336 bottles
Where it was sold
- Nationwide
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.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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