Drug 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.
D-0435-2017
Product summary
- Firm
- Sandoz Inc
- Event
- Event 75987
- Status
- Terminated
- Classification
- Class III
- Quantity
- a) 10,200 bottles; b) 300 bottles
- Official record key
drug-enforcement:D-0435-2017
Official wording
Reason: Subpotent Drug: out of specification results for assay test.
Code information: Lot #: a) FJ6599, Exp 05/17 and b) FJ6600, Exp 05/17
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Potency or specification failure
Subpotent