Candesartan Cilexetil Tablets, 16 mg, a) 30 count (NDC 00781-5938-31) and b) 90 count (NDC 00781-...
FDA Recall #D-0659-2016 — Class III — December 31, 2015
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
Reason for Recall
Failed Impurities/Degradation Specifications; 9 month stability timepoint
Recalling Firm
Sandoz Inc — Princeton, NJ
Classification
Class III — Not likely to cause adverse health consequences.
Product Type
Drugs
Product Quantity
277,267 bottles
Distribution
Nationwide
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
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated