Medi-Physics Inc. dba GE Healthcare recalls Thallous Chloride TI 201 Injection, Specific Concentration: 37 MBq/mL (1 mCi/mL), Total Activity: 325.6 MBq (8.8 mCi) V…

Recall date

March 26, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-1134-2019

FDA classification

Class III

Brand / firm

Medi-Physics Inc. dba GE Healthcare

Sold / distributed

Nationwide in the USA

Why it was recalled

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

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

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