FDA Drug recall 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, Manufac…
- FDA Drug
- Class III
- terminated
- Published 2016-08-31
On 2016-08-31 the FDA classified a Class III recall of 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, Manufac… by Exact Rx, citing crystallization; complaints received by the manufacturer of crystals forming in product.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1465-2016 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2016-06-02 |
| Published | 2016-08-31 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Exact Rx |
| Distribution | US |
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
Crystallization; complaints received by the manufacturer of crystals forming in product
Identifiers
| code_info | Lot #'s: a) 8160, b) 8160 Exp Date: 9/2018 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1465-2016%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.