Class III โ€” Low Risk

Low risk โ€” use of or exposure to this product is not likely to cause adverse health consequences.

Thallous Chloride Tl 201 Injection Recalled by Mallinckrodt Inc Due to Labeling: Correct Labeled Product Miscart/Mispack: labels on outer...

Date: July 30, 2012
Company: Mallinckrodt Inc
Status: Terminated
Source: FDA (Drug)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Mallinckrodt Inc directly.

Affected Products

Thallous Chloride Tl 201 Injection, Diagnostic Sterile, Non-Pyrogenic Solution, a) 2.8 mL (NDC 0019N12028) b) 6.3ml (NDC 0019N12063) For Intravenous Administration, each milliliter contains 37 MBq (1 mCi) Thallous Chloride Tl 201 (no carrier added) at date and time of calibration, 9 mg sodium chloride and 0.9% (v/v) benzyl alcohol as a preservative, RX, Mallinckrodt Inc., St. Louis, MO 63134

Quantity: 12/2.8mCi-vials and 12/6.3mCi-vials

Why Was This Recalled?

Labeling: Correct Labeled Product Miscart/Mispack: labels on outer containers do not match labels on vials (the correct label)

Where Was This Sold?

This product was distributed to 11 states: AZ, CA, CT, FL, MS, MO, NC, OK, PA, TX, WA

Affected (11 states)Not affected

About Mallinckrodt Inc

Mallinckrodt Inc has 2 total recalls tracked by RecallDetector.

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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report