RecallDepth
Class III Terminated

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

Company
Mallinckrodt Inc
Recall Initiated
July 30, 2012
Posted
October 3, 2012
Recall Number
D-1692-2012
Voluntary / Mandated
Voluntary: Firm initiated
Quantity
12/2.8mCi-vials and 12/6.3mCi-vials
Firm Location
Hazelwood, MO, United States

Reason for Recall

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

Distribution

AZ, CT, MO, MS, PA, FL, WA, NC, CA, TX, OK

Lot / Code Info

Lot 120-2686, exp. 8/2/12.

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