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FDAJune 2, 2016drug

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

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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

What to do

FDA enforcement status: Terminated

Brands named

exact rxexactexact rx

UPCs

4280802000542808020009

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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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 — Recall Details · AllClear