FDA-Drug2016-08-31Class III
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
Exact-Rx Inc
Hazard
Crystallization; complaints received by the manufacturer of crystals forming in product
Sold states
Nationwide
Affected count
6,310 tubes Total (3,224 tubes/5 oz & 3,086 tubes/9oz)
Manufactured in
105 Baylis Rd, Melville, NY, United States
Products
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 notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1465-2016Don't want to check this manually?
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