Reckitt Benckiser LLC recalls Polyisoprene condomns Product Usage: The Durex Synthetic polyisoprene male condom is used for contraception and for pro…

Recall date

August 6, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0091-2019

FDA classification

Class II

Brand / firm

Reckitt Benckiser LLC

Sold / distributed

US in the states of NY

Why it was recalled

Product marketed in U.S. does not have sufficient data to ensure that it will meet the internal burst pressure specifications at the end of 5 yrs shelf-life

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Polyisoprene condomns Product Usage: The Durex Synthetic polyisoprene male condom is used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted disease).