Mallinckrodt Inc recalls Thallous Chloride Tl 201 Injection, Diagnostic Sterile, Non-Pyrogenic Solution, a) 2.8 mL (NDC 0019N12028) b) 6.3ml (NDC
Recalled October 3, 2012 · FDA recall D-1692-2012 · Mallinckrodt
Hazard
Labeling: Correct Labeled Product Miscart/Mispack: labels on outer containers do not match labels on vials (the correct label) · FDA Class III
Units
12/2.8mCi-vials and 12/6.3mCi-vials
Sold at
AZ, CT, MO, MS, PA, FL, WA, NC, CA, TX, OK
Description
Labeling: Correct Labeled Product Miscart/Mispack: labels on outer containers do not match labels on vials (the correct label)
Product
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
Manufacturer(s)
Mallinckrodt Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →