Reported Oct 3, 2012 · Terminated
Thallous Chloride Tl 201 Injection, Diagnostic Sterile, Non-Pyrogenic Solution, a) 2.8 mL (NDC 0019N12028) b) 6.3ml…
Mallinckrodt Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Mallinckrodt Inc · 675 James S McDonnell Blvd · Hazelwood, MO · 63042-2301
Is this the product you have?
- 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
- Lot codes and dates
Lot 120-2686exp. 8/2/12
- Amount recalled
- 12/2.8mCi-vials and 12/6.3mCi-vials
Where it was sold
Why it was recalled
Labeling: Correct Labeled Product Miscart/Mispack: labels on outer containers do not match labels on vials (the correct label)
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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