FDAFDA · Food and drugs·Recall number D-0435-2017
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.
Published January 25, 2017 · Recall initiated: December 13, 2016
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Subpotent Drug: out of specification results for assay test.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Sandoz Inc
- Distributor
- Nationwide in the USA
- Lot
- Lot #: a) FJ6599, Exp 05/17 and b) FJ6600, Exp 05/17
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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