US Drug Recall Register
Class III · Low risk Terminated Initiated Jul 30, 2012 (14 years ago)

Thallous Chloride Tl 201 Injection

Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.

Why it was recalled

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

What was recalled

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

Recalling firm
Mallinckrodt Inc
Origin
MO, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-1692-2012

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.

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