FDAFDA · Food and drugs·Recall number D-1465-2016
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
Published August 31, 2016 · Recall initiated: June 2, 2016
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Crystallization; complaints received by the manufacturer of crystals forming in product
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Exact-Rx Inc
- Distributor
- Nationwide
- Lot
- Lot #'s: a) 8160, b) 8160 Exp Date: 9/2018
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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