Donepezil Hydrochloride Tablets recall: Subpotent
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.
Why was Donepezil Hydrochloride Tablets recalled?
Subpotent Drug: out of specification results for assay test.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot #: a) FJ6599, Exp 05/17 and b) FJ6600, Exp 05/17
- 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.
- Recalling firm
- Sandoz Inc
- Quantity
- a) 10,200 bottles; b) 300 bottles
- Distribution
- Nationwide in the USA
- Recall date
- January 25, 2017
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (drug)