D-1134-2019 Class III Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- April 17, 2019
- Initiation Date
- March 26, 2019
- Termination Date
- November 6, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 110 10 ml vials
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.
Distribution Pattern
Nationwide in the USA
Code Information
Lot: 2090-190841, Exp 3/30/3019