IA #61-06, REVISION - 2/20/98, IMPORT ALERT #61-06, "DETENTION WITHOUT
PHYSICAL EXAMINATION OF SKIN-CAP SPRAY, SHAMPOO AND
CREAM"
TYPE OF ALERT : Detention Without Physical Examination
(Note: This import alert represents the Agency's current guidance to FDA field
personnel regarding the manufacturer(s) and/or product(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.)
***This import alert is being revised to reflect Aerosoles Preval as contract
manufacturer.
PRODUCT : All products
PRODUCT CODE : GPI = DR
PROBLEM : Products from these facilities may contain a undeclared
prescription strength corticosteroid (clobetasol propionate),
although the labeling bears the active ingredient zinc
pyrithione. (OASIS CHARGE CODES: UNAPPROVED; DRUG GMPS)
PAC FOR
COLLECTION : 61D800
PROBLEM AREA
FLAG (PAF) : AAP; PER
COUNTRY : Spain (ES, 830)
MANUFACTURER/
SHIPPER : Manufacturer: Laboratorios Cheminova
Laboratorios Cheminova
International
Laboratorios Cheminova
Internacional, S.A.
Madrid, Spain
FEI# 3000384282
***Contract Manufacturer: Aerosoles Preval S.A.
Estano, 26 y 28
Apartado de Correos num. 104
28500 Arganda del Rey (Madrid), Spain
FEI# 3001151301
Distributor: ASAP Service Limited
P.O. Box N-1836, Suite A 003
Nassau, Bahamas
FEI# 3001405786
CHARGE : This 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 effective new drug
application (NDA)[Unapproved New Drug, Section 505(a)].
The products appear to be adulterated as the firm has a
history of contamination which may indicate the methods used
in, or the facilities or controls used for, its manufacture,
do not conform to or are not operated in conformity with
current good manufacturing practice [501(a)(2)(B)].
RECOMMENDING
OFFICE : CDER, Office of Compliance, Division of Labeling and
Non-Prescription Drug Compliance, HFD-310
REASON FOR
ALERT : Skin-Cap, an over-the-counter (OTC) drug for psoriasis was
found by FDA analysis to contain prescription levels of a
potent medication, the topical steroid, clobetasol propionate,
which can cause serious side effects if used incorrectly or
unknowingly. Users would be unaware of the presence of this
ingredient, as it is not declared on the labeling for the
products. Side effects from long-term use of potent topical
steroids can include stretch marks, thinning skin, and tiny
dilated blood vessels. Use of large amounts, overuse or
long-term use of potent topical steroids can also cause more
serious side effects.
Skin-Cap is an over-the counter (OTC) drug sold in various
forms (spray, cream, shampoo) that is manufactured by
Cheminova International Laboratories, Madrid, Spain, and is
available through several U.S. distributors.
Psoriasis is a chronic skin disorder that can be painful and
disabling. It is characterized by inflamed, red, scaly
lesions, caused when affected skin cells reproduce six times
faster than normal skin cells.
According to Cheminova International, the active ingredient in
Skin-Cap is zinc pyrithione (ZnP). ZnP is the same active
ingredient found in some dandruff shampoos, for which there is
no history as an effective psoriasis treatment. Zinc
pyrithione (ZnP) has never been found safe and effective for
the treatment of psoriasis. ZnP is acceptable as an OTC
product for the treatment of seborrheic dermatitis and
dandruff only.
FDA has attempted to inspect the manufacturer and ***contract
manufacturer*** to determine compliance with regard to
ingredients used in the production of all their products. The
firms have not permitted FDA inspections, therefore, we are
unable to assure manufacturing operations are in compliance
and that the use of clobetasol propionate has not extended to
other products manufactured/repacked by these firms.
GUIDANCE : All products manufactured by Cheminova and all products
repacked for Cheminova by Aerosoles Preval may be detained
without physical examination based on the refusal of Cheminova
Internacionale and Aerosoles Preval to permit FDA inspection
of their Madrid, Spain facilities.
For questions or issues concerning science, science policy,
sample collection, analysis, preparation, or analytical
methodology, contact the Division of Field Science at (301)
443-3320 or 3007.
When a shipment of productis detained without physical
examination, and the importer submits samples to a private
laboratory for analysis, if private laboratory analysis DOES
NOT INDICATE the presence of clobetasol proprionate, please
contact Robert Eshelman of CDER's Division of Labeling and
Non-Prescription Compliance at (301) 594-1065.
PRIORITIZATION
GUIDANCE : I
FOI : No purging is required.
KEYWORDS : Cheminova, Aerosols Preval, dandruff, psoriasis, seborrheic
dermatitis, unapproved prescription drug, corticosteroid, OTC
PREPARED BY : Fredda Shere-Valenti, DIOP (301) 443-6553
DATE LOADED
INTO FIARS : December 19, 1997
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