Class III
Terminated
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.
This recall has been terminated (originally issued January 25, 2017).
- Company
- Sandoz Inc
- Recall Initiated
- December 13, 2016
- Posted
- January 25, 2017
- Recall Number
- D-0435-2017
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- a) 10,200 bottles; b) 300 bottles
- Firm Location
- Princeton, NJ, United States
- Official Source
- View on FDA website ↗
Reason for Recall
Subpotent Drug: out of specification results for assay test.
Distribution
Nationwide in the USA
Lot / Code Info
Lot #: a) FJ6599, Exp 05/17 and b) FJ6600, Exp 05/17
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