January 2017 FDA Recall Drug by Mckesson Packaging Services
D-0680-2017 - Supotent
This Class III drug recall was voluntarily initiated by Mckesson Packaging Services on January 4, 2017 for the product Drug. The FDA reported the reason for recall as supotent. The product was distributed in CO, LA and OH. and the recall is currently terminated.
Recall Number: D-0680-2017
Supotent: Out of Specification result for assay test during routine stability testing.
01-04-2017
05-03-2017
476 cartons (10x10 blister packs per carton)
Recall Profile & Regulatory Data
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Mckesson Packaging Services
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
CO, LA and OH.
08-24-2017
Product Description About Product Description
Full technical description of the product.
Full technical description of the 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
Batch or Lot Expiration Information
Lot# 0111593, Exp. 05/2017
