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.