Reported Feb 17, 2016 · Terminated
Candesartan Cilexetil Tablets, 16 mg, a) 30 count (NDC 00781-5938-31) and b) 90 count (NDC 00781-5938-92) bottles, Rx…
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 · 100 College Rd W · Princeton, NJ · 08540-6604
Is this the product you have?
- 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 codes and dates
- a)b)
302228812/2015302598803/2016302598904/2016303045908/2016303046008/2016303208710/2016303208810/2016303450612/2016303595201/2017303595301/2017
302228712/2015302599004/2016303045808/2016303208609/2016303595401/2017
- a)
- Amount recalled
- 277,267 bottles
Where it was sold
- Nationwide
Why it was recalled
Failed Impurities/Degradation Specifications; 9 month stability timepoint
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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