Home / Recalls / Jubilant Draximage Inc / D-0812-2016

D-0812-2016 Class III Terminated

Recalled by Jubilant Draximage Inc — Kirkland, N/A

FDA drug recall D-0812-2016 was initiated by Jubilant Draximage Inc on Mar 11, 2016 and is designated Class III. Reason for recall: Labeling: Label Error on Declared Strength The recall status is terminated (terminated Aug 7, 2017). Affected quantity: 90 vials (450 capsules).

Recall details

Product Type: Drugs
Report Date: Apr 13, 2016
Initiation Date: Mar 11, 2016
Termination Date: Aug 7, 2017
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 90 vials (450 capsules)

Product description

SODIUM IODIDE I 131 CAPSULE, USP DIAGNOSTIC ORAL , Rx only, Manufactured by Jubilant DraxImage, Inc., Kirkland, QC, Canada, NDC 65174-461-05

Reason for recall

Labeling: Label Error on Declared Strength

Distribution pattern

Nationwide

Code information

Lot Number 1670123; Exp 04/16

Source

Dataset: openFDA drug recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for D-0812-2016
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.