Why it was recalled
Supotent: Out of Specification result for assay test during routine stability testing.
Product description
Donepezil HCl tablets, 10mg, packaged in 10x10 blister packs per carton (100 Unit Dose) container, Rx only, Manufactured by Sandoz, Inc., 506 Carnegie Center, Suite 400, Princeton, NJ 08805, Distributed by: McKesson Packaging Services, 7101 Weddington Rd, Concord, NC 28027, NDC 63739-678-10
Lot numbers, UPCs & expiration codes
Lot #0111593, Exp. 05/2017
Where it was sold
CO, LA and OH.
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-0680-2017
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Jan 4, 2017
- FDA report date
- May 3, 2017
- Quantity
- 476 cartons (10x10 blister packs per carton)
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Mckesson Packaging Services
Original FDA data
Every field from FDA enforcement report D-0680-2017, exactly as published.
Show all FDA fields
- City
- Concord
- State
- NC
- Status
- Terminated
- Country
- United States
- Event ID
- 77110
- Address
- 7101 Weddington Rd NW
- Code information
- Lot #0111593, Exp. 05/2017
- Postal code
- 28027-3412
- Report date
- May 3, 2017
- Product type
- Drugs
- Recall number
- D-0680-2017
- Classification
- Class III
- Recalling firm
- Mckesson Packaging Services
- Product quantity
- 476 cartons (10x10 blister packs per carton)
- Termination date
- Aug 24, 2017
- Reason for recall
- Supotent: Out of Specification result for assay test during routine stability testing.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Donepezil HCl tablets, 10mg, packaged in 10x10 blister packs per carton (100 Unit Dose) container, Rx only, Manufactured by Sandoz, Inc., 506 Carnegie Center, Suite 400, Princeton, NJ 08805, Distributed by: McKesson Packaging Services, 7101 Weddington Rd, Concord, NC 28027, NDC 63739-678-10
- Distribution pattern
- CO, LA and OH.
- Recall initiation date
- Jan 4, 2017
- Initial firm notification
- Letter
- Center classification date
- Apr 25, 2017