FDA-Drug2017-01-25Class III
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.
Sandoz Inc
Hazard
Subpotent Drug: out of specification results for assay test.
Sold states
Nationwide in the USA
Affected count
a) 10,200 bottles; b) 300 bottles
Manufactured in
100 College Rd W, Princeton, NJ, United States
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 Inc., Princeton, NJ 08540.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0435-2017Don't want to check this manually?
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