Donepezil Hydrochloride Tablets, 10 mg, packaged in a) 30-count bottles (NDC 0781-5275-31) and b)...
FDA Recall #D-0435-2017 — Class III — December 13, 2016
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.
Reason for Recall
Subpotent Drug: out of specification results for assay test.
Recalling Firm
Sandoz Inc — Princeton, NJ
Classification
Class III — Not likely to cause adverse health consequences.
Product Type
Drugs
Product Quantity
a) 10,200 bottles; b) 300 bottles
Distribution
Nationwide in the USA
Code Information
Lot #: a) FJ6599, Exp 05/17 and b) FJ6600, Exp 05/17
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated