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Recall Observatory FDA recall evidence

Drug product

Vyvanse (lisdexamfetamine dimesylate) Capsules 30 mg, 100 count bottle, Rx Only, Manufactured for: Shire US, Inc., Lexington, MA 02421, NDC 59417-103-10

D-0006-2017

September 02, 2016

Class III

Product summary

Firm
Shire
Event
Event 75170
Status
Terminated
Classification
Class III
Quantity
7,680 bottles (768,000 capsules)
Official record key
drug-enforcement:D-0006-2017

Official wording

Reason: Presence of Foreign Tablets/Capsules

Code information: Lot # AF3360B; Exp. 04/19

Distribution pattern: Nationwide

Derived failure modes

  • Foreign material or chemical contamination

    reason.foreign_material_chemical_contamination · v1.0.0

    Foreign Tablets