Reported Jan 25, 2017 · Terminated
Donepezil Hydrochloride Tablets, 10 mg, packaged in a) 30-count bottles (NDC 0781-5275-31) and b) 1000-count bottles…
Sandoz Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Sandoz Inc · 100 College Rd W · Princeton, NJ · 08540-6604
Is this the product you have?
- 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.
- Lot codes and dates
Lot #: a) FJ6599Exp 05/17 and b) FJ6600Exp 05/17
- Amount recalled
- a) 10,200 bottles; b) 300 bottles
Where it was sold
- Nationwide
Why it was recalled
Subpotent Drug: out of specification results for assay test.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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