FDA Drug recall D-1134-2019
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,…
- FDA Drug
- Class III
- terminated
- Published 2019-04-17
On 2019-04-17 the FDA classified a Class III recall of 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,… by Medi Physics, citing chemical Contamination: Trace amounts of an impurity was detected in the reagent used to manufacture finished product.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1134-2019 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2019-03-26 |
| Published | 2019-04-17 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Medi Physics |
| Distribution | US |
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
Chemical Contamination: Trace amounts of an impurity was detected in the reagent used to manufacture finished product.
Identifiers
| code_info | Lot: 2090-190841, Exp 3/30/3019 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1134-2019%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.