Thallous Chloride TI 201 Injection…

Date

April 17, 2019

Risk class

Class III (FDA's definition, 21 CFR 7.3(m): a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences)

Status

Terminated

Filed by

Medi-Physics Inc. dba GE Healthcare

Product

Thallous Chloride TI 201 Injection, Specific Concentration: 37 MBq/mL (1 mCi/mL), Total Activity: 325.6 MBq (8.8 mCi) Volume: 8.8 mL vial, Rx Only, Mfg. by GE Healthcare, Medi-physics, Inc., Arlington Heights, IL 60004. NDC: 17156-299-18

Reason

Chemical Contamination: Trace amounts of an impurity was detected in the reagent used to manufacture finished product.

Distribution pattern

Nationwide in the USA

Quantity

110 10 ml vials

Codes and lots

Lot: 2090-190841, Exp 3/30/3019

Recall started

March 26, 2019

Recall number

D-1134-2019

What should I do? Medicine recall: what to do

Source: FDA · Drug enforcement report, recall number D-1134-2019. The agency record governs; check it and the company before acting.