September 2016 FDA Recall Vyvanse by Shire
D-0006-2017 - Presence of Foreign Tablets/Capsules
This Class III drug recall was voluntarily initiated by Shire on September 2, 2016 for the product Vyvanse. The FDA reported the reason for recall as presence of foreign tablets/capsules. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-0006-2017
Presence of Foreign Tablets/Capsules
09-02-2016
10-12-2016
7,680 bottles (768,000 capsules)
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.
Shire
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.
Nationwide
03-08-2019
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Vyvanse (lisdexamfetamine dimesylate) Capsules 30 mg, 100 count bottle, Rx Only, Manufactured for: Shire US, Inc., Lexington, MA 02421, NDC 59417-103-10
Batch or Lot Expiration Information
Lot# AF3360B; Exp. 04/19
