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
Reported: July 12, 2017 Initiated: May 18, 2017 #D-0942-2017
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
Details
- Recalling Firm
- Lantheus MI Radipharmaceuticals Inc.
- Units Affected
- 26 doses
- Distribution
- Puerto Rico
- Location
- San Juan, PR
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Lantheus MI Radipharmaceuticals Inc.. Units affected: 26 doses.
Why was this product recalled? ▼
Failed Impurities/Degradation Specifications; out of specification result for Acetonitrile residual solvent
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on July 12, 2017. Severity: Low. Recall number: D-0942-2017.
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