FDA recall D-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

Reason for recall

Lack of Assurance of Sterility: There are also CGMP Deviations.

Distribution

Nationwide within the United States

Key facts

Status

Terminated

Initiation date

2017-02-10

Report date

2017-03-22

Termination date

2017-05-23

Voluntary/Mandated

Voluntary: Firm initiated

Location

San Diego, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0593-2017