The Recall Desk
LowFDA (Drugs)·D-1134-2019·Announced 2019-04-17

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.

What this means for you

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

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.