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) Vo
Recalled April 17, 2019 · FDA recall D-1134-2019 · Medi-Physics Inc.
Hazard
Chemical Contamination: Trace amounts of an impurity was detected in the reagent used to manufacture finished product. · FDA Class III
Units
110 10 ml vials
Sold at
Nationwide in the USA
Description
Chemical Contamination: Trace amounts of an impurity was detected in the reagent used to manufacture finished product.
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
Manufacturer(s)
Medi-Physics Inc. dba GE Healthcare
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →