Drug 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
D-0593-2017
Product summary
- Firm
- Synergy Rx
- Event
- Event 76472
- Status
- Terminated
- Classification
- Class II
- Quantity
- N/A
- Official record key
drug-enforcement:D-0593-2017
Official wording
Reason: Lack of Assurance of Sterility: There are also CGMP Deviations.
Code information: All Lots
Distribution pattern: Nationwide within the United States
Derived failure modes
-
Manufacturing or process control
CGMP Deviations
-
Sterility assurance
Lack of Assurance of Sterility