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U.S. Department of Health and Human Services

Enforcement Report - Week of October 3, 2012

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Event Detail

Event ID 62696
Product Type Drugs
Status Ongoing
Recalling Firm Mallinckrodt Inc
City Hazelwood
State MO
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-07-30
Initial Firm Notification of
Consignee or Public
Distribution Pattern AZ, CT, MO, MS, PA, FL, WA, NC, CA, TX, OK

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
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 120-2686, exp. 8/2/12. Class III Labeling: Correct Labeled Product Miscart/Mispack: labels on outer containers do not match labels on vials (the correct label) 12/2.8mCi-vials and 12/6.3mCi-vials D-1692-2012