PlainRecalls
FDA Drug Low Class III Terminated

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

Reported: April 17, 2019 Initiated: March 26, 2019 #D-1134-2019

Product Description

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.

Details

Units Affected
110 10 ml vials
Distribution
Nationwide in the USA
Location
Arlington Heights, IL

Frequently Asked Questions

What product 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. Recalled by Medi-Physics Inc. dba GE Healthcare. Units affected: 110 10 ml vials.
Why was this product recalled?
Chemical Contamination: Trace amounts of an impurity was detected in the reagent used to manufacture finished product.
Which agency issued this recall?
This recall was issued by the FDA Drug on April 17, 2019. Severity: Low. Recall number: D-1134-2019.