PlainRecalls
FDA Drug Moderate Class II Terminated

5-FLUOROURACIL IN VANICREAM, FLUOROURACIL in all strengths including 0.05%, 5% CREAM, FLUOROURACIL 4.9% IN CERAVE CREAM, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676

Reported: March 22, 2017 Initiated: February 10, 2017 #D-0527-2017

Product Description

5-FLUOROURACIL IN VANICREAM, FLUOROURACIL in all strengths including 0.05%, 5% CREAM, FLUOROURACIL 4.9% IN CERAVE CREAM, 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?
5-FLUOROURACIL IN VANICREAM, FLUOROURACIL in all strengths including 0.05%, 5% CREAM, FLUOROURACIL 4.9% IN CERAVE CREAM, 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-0527-2017.