February 2013 FDA Recall Drug by Petnet Solution Inc
D-579-2013 - cGMP Deviation

This Class II drug recall was voluntarily initiated by Petnet Solution Inc on February 22, 2013 for the product Drug. The FDA reported the reason for recall as cgmp deviation. The product was distributed in Within the state of CA. and the recall is currently terminated.

Recall Number: D-579-2013

Reason for Recall
cGMP Deviation
Initiated
02-22-2013
Reported
06-12-2013
Quantity
28 doses

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
64635
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Petnet Solution Inc
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Within the state of CA.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-06-2013
Product Description About Product Description
Full technical description of the product.
Fludeoxyglucose F 18 Injection USP, 20-200 mCi/mL, Diagnostic - For Intravenous Use Only, Manufactured by PETNET Solutions, Inc., Knoxville, TN

Batch or Lot Expiration 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]