Status
Terminated
Drug Enforcement D-1692-2012
Labeling: Correct Labeled Product Miscart/Mispack: labels on outer containers do not match labels on vials (the correct label)
Classification
Class III
Report Date
October 3, 2012
Termination Date
November 16, 2012
Product Information
- 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
- Product quantity
- 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)
- Recall initiation reason
- —
- Initial firm notification
- FAX
- Distribution pattern
- AZ, CT, MO, MS, PA, FL, WA, NC, CA, TX, OK
Location & Firm
- Recalling firm
- Mallinckrodt Inc
- Address
-
675 James S McDonnell Blvd, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-1692-2012
- Event ID
- 62696
- Recall initiation date
- July 30, 2012
- Center classification date
- September 25, 2012
- Code info
- Lot 120-2686, exp. 8/2/12.
- More code info
- —