Why it was recalled
Failed Impurities/Degradation Specifications; out of specification result for Acetonitrile residual solvent
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
Lot numbers, UPCs & expiration codes
Lot: FDG170518-01, exp 5/18/2017
Where it was sold
Puerto Rico
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0942-2017
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- May 18, 2017
- FDA report date
- Jul 12, 2017
- Quantity
- 26 doses
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Lantheus MI Radipharmaceuticals Inc.
Original FDA data
Every field from FDA enforcement report D-0942-2017, exactly as published.
Show all FDA fields
- City
- San Juan
- State
- PR
- Status
- Terminated
- Country
- United States
- Event ID
- 77433
- Address
- 150 Calle Federico Costa Ste 1
- Code information
- Lot: FDG170518-01, exp 5/18/2017
- Postal code
- 00918-1339
- Report date
- Jul 12, 2017
- Product type
- Drugs
- Recall number
- D-0942-2017
- Classification
- Class III
- Recalling firm
- Lantheus MI Radipharmaceuticals Inc.
- Product quantity
- 26 doses
- Termination date
- Dec 6, 2017
- Reason for recall
- Failed Impurities/Degradation Specifications; out of specification result for Acetonitrile residual solvent
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- Puerto Rico
- Recall initiation date
- May 18, 2017
- Initial firm notification
- Telephone
- Center classification date
- Jul 5, 2017