FDA-Drug2017-07-12Class III
Fludeoxyglucose F 18 Injection, 20mCi/mL to 200 mCi/mL at EOS, 30 mL Multiple-Dose Vial, Rx Only, Manufactured by: Lantheus MI Radiopharmaceuticals, Inc., San Juan, PR --- NDC 11994-015-01
Lantheus MI Radipharmaceuticals Inc.
Hazard
Failed Impurities/Degradation Specifications; out of specification result for Acetonitrile residual solvent
Sold states
Puerto Rico
Affected count
26 doses
Manufactured in
150 Calle Federico Costa Ste 1, N/A, San Juan, PR, United States
Products
Fludeoxyglucose F 18 Injection, 20mCi/mL to 200 mCi/mL at EOS, 30 mL Multiple-Dose Vial, Rx Only, Manufactured by: Lantheus MI Radiopharmaceuticals, Inc., San Juan, PR --- NDC 11994-015-01
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0942-2017Don't want to check this manually?
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