Donepezil Hydrochloride Tablets, 10 mg, packaged in a) 30-count bottles (NDC 0781-5275-31) and b) 1000-count bottles (NDC 0781-5275-10), Rx only, Manufactured in India by Sandoz Private Ltd for Sandoz Inc., Princeton, NJ 08540.
Recall Number: D-0435-2017
Firm: Sandoz Inc
Classification: Class III
Status: Terminated
Report Date: 20170125
Initiation Date: 20161213
Termination Date: 20170914
Reason for Recall
Subpotent Drug: out of specification results for assay test.
Product Description
Donepezil Hydrochloride Tablets, 10 mg, packaged in a) 30-count bottles (NDC 0781-5275-31) and b) 1000-count bottles (NDC 0781-5275-10), Rx only, Manufactured in India by Sandoz Private Ltd for Sandoz Inc., Princeton, NJ 08540.