FDA recall D-0435-2017

Product

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.

Reason for recall

Subpotent Drug: out of specification results for assay test.

Distribution

Nationwide in the USA

Key facts

Status

Terminated

Initiation date

2016-12-13

Report date

2017-01-25

Termination date

2017-09-14

Voluntary/Mandated

Voluntary: Firm initiated

Location

Princeton, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0435-2017