FDA recall D-1134-2019

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.

Distribution

Nationwide in the USA

Key facts

Status

Terminated

Initiation date

2019-03-26

Report date

2019-04-17

Termination date

2020-11-06

Voluntary/Mandated

Voluntary: Firm initiated

Location

Arlington Heights, IL, United States

Primary source

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