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.

FDA recall notice · announced January 25, 2017 · Sandoz

Class III FDA/FSIS Class III: use is not likely to cause adverse health consequences.

The 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.

Reason for recall

Subpotent Drug: out of specification results for assay test.

Notes

Distribution: Nationwide in the USA
Lot/code information: Lot #: a) FJ6599, Exp 05/17 and b) FJ6600, Exp 05/17
Quantity: a) 10,200 bottles; b) 300 bottles
Status: Terminated
Products in this recall event:
- 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 (D-0435-2017)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.