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IA#66-11, REVISED 9/21/92
Note: Revision to this alert updates the information and reformats
the text
of the alert.
TYPE OF ALERT: Automatic Detention
PRODUCT : Tattoo Removers
PRODUCT CODE : 66V--99
HARMONIZED
CODE : N/A
PROBLEM : New Drug without a New Drug Application (NDA) (DRND)
PAC FOR
COLLECTION : 56008H
COUNTRY : All
MANUFACTURER/
SHIPPER : All
MANUFACTURER/
SHIPPER I.D.#: N/A
IMPORTER'S
I.D. # : N/A
CHARGE : "The article is subject to refusal of admission
pursuant to
Section 801(a)(3) in that it appears to be a new
drug within
the meaning of Section 201(p) without an approved
new drug
application [Unapproved New Drug, Section 505(a)]."
RECOMMENDING
OFFICE : CDER/OTC Compliance Branch, HFD-312
REASON FOR
ALERT : Three complaints of injury have implicated this drug
as the
source of acute inflammation, cellulitis and
secondary
infection of the skin. All of the complaints
indicated that
the tattoo remover was received through the mail
from the
Atlanta Co., Pickering, Ontario, Canada.
The product was received in small plastic vials
labeled in
part, "Tatex Tattoo Remover*** 2 1/2 cc accompanied
by
labeling entitled, "Instructions for use of the
Tatex Tattoo
Remover."
Although there has been no recent detention activity
of the
Tatex brand tattoo remover, the alert remains in
effect
because of the possibility of entry which may be
attempted for
similar products from other foreign manufacturers.
INSTRUCTIONS : Detain products which claim to be tattoo removers.
Notify
CDER/OTC Labeling Branch at 301-295-8063 when
detentions of
these products are made.
PRIORITIZATION
GUIDANCE : N/A
FOI : No purging required.
KEYWORDS : Tattoo remover, New Drug, Tatex Tattoo Remover,
skin,
infection
PREPARED BY : Linda A. Wisniowski, DIOP, 301-443-6553.