PlainRecalls
FDA Drug Moderate Class II Terminated

SALICYLIC ACID SOLUTION in all strengths including 20%, 25%, 30%, and 40%, SALICYCLIC ACID 20%. 2.5%5-FU, SALICYCLIC ACID 20%, 5-FU 2.5% CREAM, SALICYCLIC ACID 20%/5-FU 2.5% MEDICATION STICK, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676

Reported: March 22, 2017 Initiated: February 10, 2017 #D-0543-2017

Product Description

SALICYLIC ACID SOLUTION in all strengths including 20%, 25%, 30%, and 40%, SALICYCLIC ACID 20%. 2.5%5-FU, SALICYCLIC ACID 20%, 5-FU 2.5% CREAM, SALICYCLIC ACID 20%/5-FU 2.5% MEDICATION STICK, 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.

Details

Recalling Firm
Synergy Rx
Units Affected
N/A
Distribution
Nationwide within the United States
Location
San Diego, CA

Frequently Asked Questions

What product was recalled?
SALICYLIC ACID SOLUTION in all strengths including 20%, 25%, 30%, and 40%, SALICYCLIC ACID 20%. 2.5%5-FU, SALICYCLIC ACID 20%, 5-FU 2.5% CREAM, SALICYCLIC ACID 20%/5-FU 2.5% MEDICATION STICK, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676. Recalled by Synergy Rx. Units affected: N/A.
Why was this product recalled?
Lack of Assurance of Sterility: There are also CGMP Deviations.
Which agency issued this recall?
This recall was issued by the FDA Drug on March 22, 2017. Severity: Moderate. Recall number: D-0543-2017.