Enforcement Report - Week of October 3, 2012
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Product Detail
| Product Description | 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 |
|---|---|
| Recall Number | D-1692-2012 |
| Classification | Class III |
| Code Info | Lot 120-2686, exp. 8/2/12. |
| Product Distributed Qty | 12/2.8mCi-vials and 12/6.3mCi-vials |
| Reason For Recall | Labeling: Correct Labeled Product Miscart/Mispack: labels on outer containers do not match labels on vials (the correct label) |
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 | FAX |
| Distribution Pattern | AZ, CT, MO, MS, PA, FL, WA, NC, CA, TX, OK |
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