D-0942-2017 Class III Terminated
FDA drug recall D-0942-2017 was initiated by Lantheus MI Radipharmaceuticals Inc. on May 18, 2017 and is designated Class III. Reason for recall: Failed Impurities/Degradation Specifications; out of specification result for Acetonitrile residual solvent The recall status is terminated (terminated December 6, 2017). Affected quantity: 26 doses.
Recall Details
- Product Type
- Drugs
- Report Date
- July 12, 2017
- Initiation Date
- May 18, 2017
- Termination Date
- December 6, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 26 doses
Product Description
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
Distribution Pattern
Puerto Rico
Code Information
Lot: FDG170518-01, exp 5/18/2017