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D-0006-2017 Class III Terminated

Recalled by Shire — Chesterbrook, PA

FDA drug recall D-0006-2017 was initiated by Shire on Sep 2, 2016 and is designated Class III. Reason for recall: Presence of Foreign Tablets/Capsules The recall status is terminated (terminated Mar 8, 2019). Affected quantity: 7,680 bottles (768,000 capsules).

Recall details

Product Type: Drugs
Report Date: Oct 12, 2016
Initiation Date: Sep 2, 2016
Termination Date: Mar 8, 2019
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 7,680 bottles (768,000 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

Reason for recall

Presence of Foreign Tablets/Capsules

Distribution pattern

Nationwide

Code information

Lot # AF3360B; Exp. 04/19

Source

Dataset: openFDA drug recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for D-0006-2017
openFDA file date: Nov 10, 2026
Loaded by RegDataLab: Nov 11, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.