Why it was recalled
Presence of Foreign Tablets/Capsules
Product description
Vyvanse (lisdexamfetamine dimesylate) Capsules 30 mg, 100 count bottle, Rx Only, Manufactured for: Shire US, Inc., Lexington, MA 02421, NDC 59417-103-10
Lot numbers, UPCs & expiration codes
Lot # AF3360B; Exp. 04/19
Where it was sold
Nationwide
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-0006-2017
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Sep 2, 2016
- FDA report date
- Oct 12, 2016
- Quantity
- 7,680 bottles (768,000 capsules)
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Shire
Original FDA data
Every field from FDA enforcement report D-0006-2017, exactly as published.
Show all FDA fields
- City
- Chesterbrook
- State
- PA
- Status
- Terminated
- Country
- United States
- Event ID
- 75170
- Address
- 1200 Morris Dr
- Code information
- Lot # AF3360B; Exp. 04/19
- Postal code
- 19087-5507
- Report date
- Oct 12, 2016
- Product type
- Drugs
- Recall number
- D-0006-2017
- Classification
- Class III
- Recalling firm
- Shire
- Product quantity
- 7,680 bottles (768,000 capsules)
- Termination date
- Mar 8, 2019
- Reason for recall
- Presence of Foreign Tablets/Capsules
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Vyvanse (lisdexamfetamine dimesylate) Capsules 30 mg, 100 count bottle, Rx Only, Manufactured for: Shire US, Inc., Lexington, MA 02421, NDC 59417-103-10
- Distribution pattern
- Nationwide
- Recall initiation date
- Sep 2, 2016
- Initial firm notification
- Letter
- Center classification date
- Oct 5, 2016