UREA 40% Cream — Class II drug recall D-0545-2017
Terminated recall by Synergy Rx, reported 2017-03-22, distributed nationwide. Lack of Assurance of Sterility: There are also CGMP Deviations.
| Recall number | D-0545-2017 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Synergy Rx, San Diego, CA, United States |
| Recall initiated | 2017-02-10 |
| Classified | 2017-03-15 |
| Reported by FDA | 2017-03-22 |
| Terminated | 2017-05-23 |
| Distributed | Nationwide (US) |
| Reason classes | sterility, cgmp |
Product
UREA 40% Cream, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
Reason for recall
Lack of Assurance of Sterility: There are also CGMP Deviations.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0545-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.