Recalls / Class III
Class IIID-0680-2017
Product
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
- Affected lot / code info
- Lot #0111593, Exp. 05/2017
Why it was recalled
Supotent: Out of Specification result for assay test during routine stability testing.
Recalling firm
- Firm
- Mckesson Packaging Services
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 7101 Weddington Rd NW, N/A, Concord, North Carolina 28027-3412
Distribution
- Quantity
- 476 cartons (10x10 blister packs per carton)
- Distribution pattern
- CO, LA and OH.
Timeline
- Recall initiated
- 2017-01-04
- FDA classified
- 2017-04-25
- Posted by FDA
- 2017-05-03
- Terminated
- 2017-08-24
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0680-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.