Sandoz Inc recalls Donepezil Hydrochloride Tablets, 10 mg, packaged in a) 30-count bottles (NDC 0781-5275-31) and b) 1000-count bottles (N…

Recall date

December 13, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-0435-2017

FDA classification

Class III

Brand / firm

Sandoz Inc

Sold / distributed

Nationwide in the USA

Why it was recalled

Subpotent Drug: out of specification results for assay test.

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

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.