FDA recall D-1465-2016

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

Reason for recall

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

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2016-06-02

Report date

2016-08-31

Termination date

2018-06-14

Voluntary/Mandated

Voluntary: Firm initiated

Location

Melville, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1465-2016