Mallinckrodt Recalls Thallous Chloride Tl 201 Injection Due to Labeling Mismatch
Mallinckrodt Inc. is recalling specific lots of Thallous Chloride Tl 201 Injection because outer container labels do not match the vial labels.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences. The issue is a packaging/labeling mismatch rather than a contamination or dosage error.
Plain-English summary
Mallinckrodt Inc. is recalling Thallous Chloride Tl 201 Injection, a diagnostic sterile, non-pyrogenic solution for intravenous administration. The recall involves Lot 120-2686, which has an expiration date of 8/2/12. The product is available in 2.8 mL and 6.3 mL vials, packaged in quantities of 12 vials per box.
The recall was initiated due to a labeling discrepancy where the labels on the outer containers do not match the labels on the individual vials. This is classified as a Class III recall by the FDA, indicating that the use of or exposure to the product is not likely to cause adverse health consequences.
The affected product was distributed in Arizona, Connecticut, Missouri, Mississippi, Pennsylvania, Florida, Washington, North Carolina, California, Texas, and Oklahoma. Healthcare providers and patients should verify that the vial labels match the outer container labels before administration. If a mismatch is found, the product should not be used.
The recalled product
- 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
- Manufacturer
- Mallinckrodt Inc
- Category
- Drug — Radiopharmaceutical
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot 120-2686
- exp. 8/2/12.
Distribution
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