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

FDA recall notice · announced April 17, 2019 · Medi-physics Inc. Dba Ge Healthcare

Class III FDA/FSIS Class III: use is not likely to cause adverse health consequences.

The 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 for recall

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

Notes

Distribution: Nationwide in the USA
Lot/code information: Lot: 2090-190841, Exp 3/30/3019
Quantity: 110 10 ml vials
Status: Terminated
Products in this recall event:
- 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 (D-1134-2019)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.