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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Low RiskFDA Drug
Medications & Supplements/Prescription Drugs

Medi-Physics Inc. dba GE Healthcare: Thallous Chloride TI 201 Injection Recalled for Chemical Contamination

Agency Publication Date: April 11, 2019
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Summary

Medi-Physics Inc. dba GE Healthcare is recalling 110 vials of Thallous Chloride TI 201 Injection, a prescription radiopharmaceutical drug used in medical imaging. The recall was initiated because trace amounts of an impurity were detected in a reagent used during the manufacturing process, which could contaminate the finished product. Consumers should be aware that this specific lot was distributed nationwide across the United States.

Risk

The presence of trace impurities in an injectable medication may lead to unintended chemical exposure. While the risk level is currently categorized as low, contaminated reagents can compromise the purity and safety of the final drug product.

What You Should Do

  1. Check your medical supplies for Thallous Chloride TI 201 Injection (37 MBq/mL) in 10 mL vials with NDC 17156-299-18.
  2. Verify if the vial belongs to Lot 2090-190841 with an expiration date of 3/30/3019 (noted as 2019 in records).
  3. If you identify an affected vial, do not use the product and quarantine it immediately to prevent administration to patients.
  4. Contact your healthcare provider or pharmacist for guidance regarding the use of this medication and to report any potential adverse effects.
  5. Return any unused product from the affected lot to the pharmacy or place of purchase for a refund and contact GE Healthcare at their Arlington Heights facility for further instructions.
  6. For additional questions or to report a complaint, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA).

Your Remedy Options

💰Full Refund

Healthcare provider consultation and pharmacy return.

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund.

Affected Products

Product: Thallous Chloride TI 201 Injection, 37 MBq/mL (1 mCi/mL) (8.8 mL vial)
Model:
NDC 17156-299-18
Recall #: D-1134-2019
Lot Numbers:
2090-190841 (Exp 3/30/3019)
Date Ranges: Expiration date: 3/30/3019

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 82567
Status: Resolved
Manufacturer: Medi-Physics Inc. dba GE Healthcare
Sold By: hospitals; radiopharmacies; medical clinics
Manufactured In: United States
Units Affected: 110 10 ml vials
Distributed To: Nationwide
Agency Last Updated: April 16, 2019

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.