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

FDA recall notice · announced July 12, 2017 · Lantheus Mi Radipharmaceuticals

Class III FDA/FSIS Class III: use is not likely to cause adverse health consequences.

The product

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

Reason for recall

Failed Impurities/Degradation Specifications; out of specification result for Acetonitrile residual solvent

Notes

Distribution: Puerto Rico
Lot/code information: Lot: FDG170518-01, exp 5/18/2017
Quantity: 26 doses
Status: Terminated
Products in this recall event:
- 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 (D-0942-2017)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.