FDA Drug Class III — Least Serious

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.

Hazard

Subpotent Drug: out of specification results for assay test.

Products

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
Brand
Sandoz Inc
UPC
Lot #: a) FJ6599, Exp 05/17 and b) FJ6600, Exp 05/17

Units Affected

a) 10,200 bottles; b) 300 bottles