D-1692-2012 Class III Terminated
FDA drug recall D-1692-2012 was initiated by Mallinckrodt Inc on July 30, 2012 and is designated Class III. Reason for recall: Labeling: Correct Labeled Product Miscart/Mispack: labels on outer containers do not match labels on vials (the correct label) The recall status is terminated (terminated November 16, 2012). Affected quantity: 12/2.8mCi-vials and 12/6.3mCi-vials.
Recall Details
- Product Type
- Drugs
- Report Date
- October 3, 2012
- Initiation Date
- July 30, 2012
- Termination Date
- November 16, 2012
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 12/2.8mCi-vials and 12/6.3mCi-vials
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
Reason for Recall
Labeling: Correct Labeled Product Miscart/Mispack: labels on outer containers do not match labels on vials (the correct label)
Distribution Pattern
AZ, CT, MO, MS, PA, FL, WA, NC, CA, TX, OK
Code Information
Lot 120-2686, exp. 8/2/12.