Import Alert 66-11
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(Note: This import alert represents the Agency's current guidance to FDA field personnel regarding the manufacturer(s) and/or products(s) at issue. It does not create or confer any rights for or on any person, and does not operate to bind FDA or the public).
Import Alert # 66-11
Published Date: 12/07/2012
Type: DWPE
Import Alert Name:
"Tatex Tattoo Remover"
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.
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.
Guidance:
Districts may detain without physical examination products which claim to be tattoo removers.
Product Description:
Tattoo Removers
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)]."
OASIS charge code - UNAPPROVED
OASIS charge code - UNAPPROVED
Countries
MULTIPLE COUNTRIES (PODS ONLY)
(66 V - - 99) Miscellaneous Patent Medicines, Etc.
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