Recalls / Class II
Class IID-0593-2017
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
- Affected lot / code info
- All Lots
Why it was recalled
Lack of Assurance of Sterility: There are also CGMP Deviations.
Recalling firm
- Firm
- Synergy Rx
- Notification channel
- Telephone
- Type
- Voluntary: Firm initiated
- Address
- 4901 Morena Blvd Ste 504A, N/A, San Diego, California 92117-7310
Distribution
- Quantity
- N/A
- Distribution pattern
- Nationwide within the United States
Timeline
- Recall initiated
- 2017-02-10
- FDA classified
- 2017-03-15
- Posted by FDA
- 2017-03-22
- Terminated
- 2017-05-23
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0593-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.