Why it was recalled
cGMP Deviation
Product description
Fludeoxyglucose F 18 Injection USP, 20-200 mCi/mL, Diagnostic - For Intravenous Use Only, Manufactured by PETNET Solutions, Inc., Knoxville, TN
Lot numbers, UPCs & expiration codes
Batch # BN-3350 Rx #s: [38126044] [38126058] [38126059] [38126021] [38126022] [38126023] [38125981] [38125991] [38125992] [38126016] [38126017] [38126004] [38126005] [38126006] [38126007] [38126057] [38125999] [38126036] [38126037] [38126038] [38125998] [38126033]
Where it was sold
Within the state of CA.
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-579-2013
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Feb 22, 2013
- FDA report date
- Jun 12, 2013
- Quantity
- 28 doses
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Petnet Solution Inc
Original FDA data
Every field from FDA enforcement report D-579-2013, exactly as published.
Show all FDA fields
- City
- Irvine
- State
- CA
- Status
- Terminated
- Country
- United States
- Event ID
- 64635
- Address
- 835 Health Sciences Rd
- Code information
- Batch # BN-3350 Rx #s: [38126044] [38126058] [38126059] [38126021] [38126022] [38126023] [38125981] [38125991] [38125992] [38126016] [38126017] [38126004] [38126005] [38126006] [38126007] [38126057] [38125999] [38126036] [38126037] [38126038] [38125998] [38126033]
- Postal code
- 92617-3058
- Report date
- Jun 12, 2013
- Product type
- Drugs
- Recall number
- D-579-2013
- Classification
- Class II
- Recalling firm
- Petnet Solution Inc
- Product quantity
- 28 doses
- Termination date
- Jun 6, 2013
- Reason for recall
- cGMP Deviation
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Fludeoxyglucose F 18 Injection USP, 20-200 mCi/mL, Diagnostic - For Intravenous Use Only, Manufactured by PETNET Solutions, Inc., Knoxville, TN
- Distribution pattern
- Within the state of CA.
- Recall initiation date
- Feb 22, 2013
- Initial firm notification
- Telephone
- Center classification date
- Jun 6, 2013