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 42808-0200-09
Recalled August 31, 2016 · FDA recall D-1465-2016 · Exact-Rx
Hazard
Crystallization; complaints received by the manufacturer of crystals forming in product · FDA Class III
Units
6,310 tubes Total (3,224 tubes/5 oz & 3,086 tubes/9oz)
Sold at
Nationwide
Description
Crystallization; complaints received by the manufacturer of crystals forming in product
Product
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
Manufacturer(s)
Exact-Rx Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →