CLASS III Drug recall · Reported 17 Apr 2019 · FDA Enforcement Report
Thallous Chloride TI 201 Injection, Specific Concentration recalled
Medi-Physics is recalling Thallous Chloride TI 201 Injection, Specific Concentration: 37 MBq/mL (1 mCi/mL), Total, distributed nationwide in the US. The recall was initiated on 26 Mar 2019 and the FDA has classified it as Class III.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-1134-2019
- FDA event ID
- 82567
- Recalling firm
- Medi-Physics, Arlington Heights, IL
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 26 Mar 2019
- FDA classified
- 16 Apr 2019
- Reported
- 17 Apr 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Telephone
- Reason category
- Potency & Assay
- Drug class
- Injectable & IV Drugs
Timeline
| 26 Mar 2019 | Recall initiated by company | |
| 16 Apr 2019 | Classified by FDA | +21 days |
| 17 Apr 2019 | Published in enforcement report | +1 day |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Chemical Contamination: Trace amounts of an impurity was detected in the reagent used to manufacture finished product.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
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
Where it was distributed
Nationwide in the USA
Questions about this recall
Is Thallous Chloride TI 201 Injection, Specific Concentration: 37 MBq/mL (1 mCi/mL), Total recalled?
Yes. Medi-Physics recalled Thallous Chloride TI 201 Injection, Specific Concentration: 37 MBq/mL (1 mCi/mL), Total on 26 Mar 2019. The recall is Class III and its status is Terminated. Recall number D-1134-2019.
Why was it recalled?
Chemical Contamination: Trace amounts of an impurity was detected in the reagent used to manufacture finished product.
Which lots are affected?
Lot: 2090-190841, Exp 3/30/3019
Where was it sold?
Nationwide in the USA
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.