FDA Drug recall D-0593-2017
LIDOCAINE CREAM in all strengths including: 5%, 8%, 23%, 30%, LIDOCAINE / PRILOCAINE / MELYLEPHRINE 15% / 5% / 0.5% CREAM, LIDOCAINE / PRIL…
- FDA Drug
- Class II
- terminated
- Published 2017-03-22
On 2017-03-22 the FDA classified a Class II recall of LIDOCAINE CREAM in all strengths including: 5%, 8%, 23%, 30%, LIDOCAINE / PRILOCAINE / MELYLEPHRINE 15% / 5% / 0.5% CREAM, LIDOCAINE / PRIL… by Synergy Rx, citing lack of Assurance of Sterility: There are also CGMP Deviations.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0593-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-02-10 |
| Published | 2017-03-22 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Synergy Rx |
| Distribution | US |
Product
LIDOCAINE CREAM in all strengths including: 5%, 8%, 23%, 30%, LIDOCAINE / PRILOCAINE / MELYLEPHRINE 15% / 5% / 0.5% CREAM, LIDOCAINE / PRILOCAINE / MELYLEPHRINE 15% / 5% / 0.5% OINTMENT LIDOCAINE 23%/ TETRACAINE 7% CREAM, LIDOCAINE 23%/TETRACAINE 7% OINTMENT, LIDOCAINE 23%/TETRACAINE 7%/PRILOCAONE 2.5%, LIDOCAINE 24%/PRILOCAINE 26% OINTMENT, LIDOCAINE 30%/TETRACAINE 4% /PRILOCAINE 2%, LIDOCAINE 30%/PHENYLEPHRINE 0.25%, LIDOCAINE 30%/ TETRACAINE 10%, MELYLEPHRINE 4%, LIDOCAINE 30%/TETRACAINE 4%/PRILOCAINE, LIDOCAINE 7%/TETRACAINE 7% CREAM, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
Reason
Lack of Assurance of Sterility: There are also CGMP Deviations.
Identifiers
| code_info | All Lots |
|---|
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-0593-2017%22
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