Drug 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
D-1134-2019
Product summary
- Event
- Event 82567
- Status
- Terminated
- Classification
- Class III
- Quantity
- 110 10 ml vials
- Official record key
drug-enforcement:D-1134-2019
Official wording
Reason: Chemical Contamination: Trace amounts of an impurity was detected in the reagent used to manufacture finished product.
Code information: Lot: 2090-190841, Exp 3/30/3019
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Foreign material or chemical contamination
Chemical Contamination