Fludeoxyglucose F 18 Injection USP, 20-200 mCi/mL, Diagnostic - For Intravenous Use Only, Manufactured by PETNET Solutions, Inc., Knoxville, TN

FDA recall notice · announced June 12, 2013 · Petnet Solution

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The product

Fludeoxyglucose F 18 Injection USP, 20-200 mCi/mL, Diagnostic - For Intravenous Use Only, Manufactured by PETNET Solutions, Inc., Knoxville, TN

Reason for recall

cGMP Deviation

Notes

Distribution: Within the state of CA.
Lot/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]
Quantity: 28 doses
Status: Terminated
Products in this recall event:
- Fludeoxyglucose F 18 Injection USP, 20-200 mCi/mL, Diagnostic - For Intravenous Use Only, Manufactured by PETNET Solutions, Inc., Knoxville, TN (D-579-2013)

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