Drug 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
D-1692-2012
Product summary
- Firm
- Mallinckrodt Inc
- Event
- Event 62696
- Status
- Terminated
- Classification
- Class III
- Quantity
- 12/2.8mCi-vials and 12/6.3mCi-vials
- Official record key
drug-enforcement:D-1692-2012
Official wording
Reason: Labeling: Correct Labeled Product Miscart/Mispack: labels on outer containers do not match labels on vials (the correct label)
Code information: Lot 120-2686, exp. 8/2/12.
Distribution pattern: AZ, CT, MO, MS, PA, FL, WA, NC, CA, TX, OK
Derived failure modes
-
Unknown
Labeling: Correct Labeled Product Miscart/Mispack: labels on outer containers do not match labels on vials (the correct label)