New Drug without a New Drug Application (NDA) (DRND)
PAC FOR COLLECTION
56008H
COUNTRY
All
MANUFACTURER/SHIPPER
All
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.
