Exact-Rx Inc recalls Urea (50% Urea in a Cream Base), a) Net Wt. 5 oz (142 g), (NDC 42808-0200-05) b) Net Wt. 9 oz (225 g) (NDC 42808-0200-0…

Recall date

June 2, 2016

Source

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

Recall number

D-1465-2016

FDA classification

Class III

Brand / firm

Exact-Rx Inc

Sold / distributed

Nationwide

Why it was recalled

Crystallization; complaints received by the manufacturer of crystals forming in product

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

Urea (50% Urea in a Cream Base), a) Net Wt. 5 oz (142 g), (NDC 42808-0200-05) b) Net Wt. 9 oz (225 g) (NDC 42808-0200-09), Rx Only, Manufactured in the U.S.A. for Exact-Rx Inc., Melville, NY