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Tuesday, March 31, 2009Authorities

Afssaps Alert: Removal of lots of ABCDerm Maman Vergetures from Bioderma Laboratories

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The Bioderma laboratory, in agreement with the Afssaps, proceeds with the withdrawal of all batches whose expiry date is before or equal to September 2011 of the cosmetic product "ABCDerm Maman Vergetures", capacity 200 ml (ACL 471 695.9). Indeed, Bioderma laboratory noted during the use of this product cases of delayed onset contact dermatitis. Investigations are under way to determine the origin of these demonstrations, which has not yet been clearly identified. Furthermore, the Afssaps recommends that women who hold this cosmetic product no longer use it and return it to the points of sale.

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April 1, 2009
In addition to this decision, the Afssaps published an explanatory communiqué, the full text of which follows:

Following the occurrence of adverse reactions and as a precautionary measure, the Bioderma laboratory, in agreement with the Afssaps, proceeds with the withdrawal of all batches of the cosmetic product ABCDerm Maman Vergetures whose expiry date is before or equal to September 2011. The Afssaps recommends that persons who hold this cosmetic product no longer use it and return it to the point of sale.Afssaps was recently the recipient of 5 adverse reaction reports (delayed onset contact dermatitis);e manifested notably by redness and itching) in pregnant women after use of the cosmetic product ABCDerm Maman Vergetures marketed by the laboratory Bioderma. This cosmetic product is mainly used in pregnant women or after pregnancy to prevent or reduce stretch marks.The origin of these adverse reactions, which have evolved favourably, has not yet been clearly identified, and investigations are under way to determine their origin. Although these adverse reactions are not serious in nature, as a precautionary measure, the Bioderma laboratory, in agreement with the Afssaps, is withdrawing from the market all the lots whose expiry date is before or equal to September 2011 in the points of sale.In France, since the marketing of this cosmetic product in January 2008, 8339 tubes have been distributed in pharmacies and parapharmacies.The Afssaps recommends that people who have a tube of the product ABCDerm Maman Vergetures not to use it and to take it back to their point of sale.
The Afssaps recalls that any adverse reaction following the use of cosmetic products must be reported to the Agency.

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