Thallous Chloride TI 201 Injection recall: Impurity Out of Spec
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…
Why was Thallous Chloride TI 201 Injection recalled?
Chemical Contamination: Trace amounts of an impurity was detected in the reagent used to manufacture finished product.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot: 2090-190841, Exp 3/30/3019
- 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…
- Recalling firm
- Medi-Physics Inc. dba GE Healthcare
- Quantity
- 110 10 ml vials
- Distribution
- Nationwide in the USA
- Recall date
- April 17, 2019
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (drug)