FDA recall D-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

Reason for recall

Labeling: Correct Labeled Product Miscart/Mispack: labels on outer containers do not match labels on vials (the correct label)

Distribution

AZ, CT, MO, MS, PA, FL, WA, NC, CA, TX, OK

Key facts

Status

Terminated

Initiation date

2012-07-30

Report date

2012-10-03

Termination date

2012-11-16

Voluntary/Mandated

Voluntary: Firm initiated

Location

Hazelwood, MO, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1692-2012