Why it was recalled
Subpotent Drug: out of specification results for assay test.
Product description
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 numbers, UPCs & expiration codes
Lot #: a) FJ6599, Exp 05/17 and b) FJ6600, Exp 05/17
Where it was sold
Nationwide in the USA
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0435-2017
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Dec 13, 2016
- FDA report date
- Jan 25, 2017
- Quantity
- a) 10,200 bottles; b) 300 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Sandoz Inc
Original FDA data
Every field from FDA enforcement report D-0435-2017, exactly as published.
Show all FDA fields
- City
- Princeton
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 75987
- Address
- 100 College Rd W
- Code information
- Lot #: a) FJ6599, Exp 05/17 and b) FJ6600, Exp 05/17
- Postal code
- 08540-6604
- Report date
- Jan 25, 2017
- Product type
- Drugs
- Recall number
- D-0435-2017
- Classification
- Class III
- Recalling firm
- Sandoz Inc
- Product quantity
- a) 10,200 bottles; b) 300 bottles
- Termination date
- Sep 14, 2017
- Reason for recall
- Subpotent Drug: out of specification results for assay test.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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.
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Dec 13, 2016
- Initial firm notification
- Letter
- Center classification date
- Jan 19, 2017