Recalls / Class III
Class IIID-0435-2017
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.
- Affected lot / code info
- Lot #: a) FJ6599, Exp 05/17 and b) FJ6600, Exp 05/17
Why it was recalled
Subpotent Drug: out of specification results for assay test.
Recalling firm
- Firm
- Sandoz Inc
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 100 College Rd W, Princeton, New Jersey 08540-6604
Distribution
- Quantity
- a) 10,200 bottles; b) 300 bottles
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2016-12-13
- FDA classified
- 2017-01-19
- Posted by FDA
- 2017-01-25
- Terminated
- 2017-09-14
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0435-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.