Recalls / Class III
Class IIID-1692-2012
Product
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
- Affected lot / code info
- Lot 120-2686, exp. 8/2/12.
Why it was recalled
Labeling: Correct Labeled Product Miscart/Mispack: labels on outer containers do not match labels on vials (the correct label)
Recalling firm
- Firm
- Mallinckrodt Inc
- Notification channel
- FAX
- Type
- Voluntary: Firm initiated
- Address
- 675 James S McDonnell Blvd, N/A, Hazelwood, Missouri 63042-2301
Distribution
- Quantity
- 12/2.8mCi-vials and 12/6.3mCi-vials
- Distribution pattern
- AZ, CT, MO, MS, PA, FL, WA, NC, CA, TX, OK
Timeline
- Recall initiated
- 2012-07-30
- FDA classified
- 2012-09-25
- Posted by FDA
- 2012-10-03
- Terminated
- 2012-11-16
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1692-2012. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.