Drug Enforcement D-579-2013

cGMP Deviation

Status

Terminated

Classification

Class II

Report Date

June 12, 2013

Termination Date

June 6, 2013

Product Information

Product description
Fludeoxyglucose F 18 Injection USP, 20-200 mCi/mL, Diagnostic - For Intravenous Use Only, Manufactured by PETNET Solutions, Inc., Knoxville, TN
Product quantity
28 doses
Reason for recall
cGMP Deviation
Recall initiation reason
—
Initial firm notification
Telephone
Distribution pattern
Within the state of CA.

Location & Firm

Recalling firm
Petnet Solution Inc
Address
835 Health Sciences Rd, N/A

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-579-2013
Event ID
64635
Recall initiation date
February 22, 2013
Center classification date
June 6, 2013
Code info
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]
More code info
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