Recalls / Class III
Class IIID-0006-2017
Product
Vyvanse (lisdexamfetamine dimesylate) Capsules 30 mg, 100 count bottle, Rx Only, Manufactured for: Shire US, Inc., Lexington, MA 02421, NDC 59417-103-10
- Brand name
- Vyvanse
- Generic name
- Lisdexamfetamine Dimesylate
- Active ingredient
- Lisdexamfetamine Dimesylate
- Route
- Oral
- NDCs
- 59417-101, 59417-102, 59417-103, 59417-104, 59417-105, 59417-106, 59417-107, 59417-115, 59417-116, 59417-117 +3 more
- FDA application
- NDA021977
- Affected lot / code info
- Lot # AF3360B; Exp. 04/19
Why it was recalled
Presence of Foreign Tablets/Capsules
Recalling firm
- Firm
- Shire
- Manufacturer
- Takeda Pharmaceuticals America, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1200 Morris Dr, N/A, Chesterbrook, Pennsylvania 19087-5507
Distribution
- Quantity
- 7,680 bottles (768,000 capsules)
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2016-09-02
- FDA classified
- 2016-10-05
- Posted by FDA
- 2016-10-12
- Terminated
- 2019-03-08
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0006-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.