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

FDA recall notice · announced August 31, 2016 · Exact-rx

Class III FDA/FSIS Class III: use is not likely to cause adverse health consequences.

The 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

Notes

Distribution: Nationwide
Lot/code information: Lot #'s: a) 8160, b) 8160 Exp Date: 9/2018
Quantity: 6,310 tubes Total (3,224 tubes/5 oz & 3,086 tubes/9oz)
Status: Terminated
Products in this recall event:
- 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 (D-1465-2016)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.