GE Healthcare Recalls Thallous Chloride TI 201 Injection Due to Chemical Contamination
Medi-Physics Inc. dba GE Healthcare is recalling Thallous Chloride TI 201 Injection vials because trace amounts of an impurity were detected in the manufacturing reagent.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The FDA classified this recall as Class III, which the rubric defines as unlikely to cause adverse health consequences, typically corresponding to a Low severity score.
Plain-English summary
Medi-Physics Inc. dba GE Healthcare is recalling 110 vials of Thallous Chloride TI 201 Injection, NDC 17156-299-18. The affected product is a prescription-only radiopharmaceutical with a specific concentration of 37 MBq/mL (1 mCi/mL) and a total activity of 325.6 MBq (8.8 mCi) in an 8.8 mL vial. The specific lot number is 2090-190841, with an expiration date of 3/30/3019.
The recall was initiated due to chemical contamination. Trace amounts of an impurity were detected in the reagent used to manufacture the finished product. The FDA has classified this recall as Class III, indicating that use of, or exposure to, the violative product is not likely to cause adverse health consequences.
The affected product was distributed nationwide in the USA. Healthcare providers and patients should stop using the affected lot and contact the manufacturer or their supplier for further instructions on returns or replacements.
The recalled product
- 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
- Manufacturer
- Medi-Physics Inc. dba GE Healthcare
- Category
- Drug — Radiopharmaceutical
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot: 2090-190841
- Exp 3/30/3019
Distribution
Distributed nationwide across the United States.
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