FDA-Drug2019-04-17Class III

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

Medi-Physics Inc. dba GE Healthcare
Hazard

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

Sold states
Nationwide in the USA
Affected count
110 10 ml vials
Manufactured in
3350 N Ridge Ave, N/A, Arlington Heights, IL, United States
Products
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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1134-2019

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