FDA Drug · D-0537-2017

FLUORORACIL 0.05% CREAM, FLUORORACIL 5% CREAM, FLUOROURACIL 4.9% IN CERAVE CREAM, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676

Class II · Terminated

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

Affected lots / codes — check yours against thisAll Lots

Recalling firm: Synergy Rx, San Diego, CA
Classification: Class II (temporary or reversible harm possible)
Status: Terminated
Quantity: N/A
Distribution: Nationwide within the United States
Recall initiated: February 10, 2017
Classified: March 15, 2017
Terminated: May 23, 2017
Initiation: Voluntary: Firm initiated

Official source. This record is published by the U.S. FDA through the openFDA enforcement database. View the unmodified government record:
https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0537-2017%22

Important. Recalls target specific lots and codes — compare the affected lots above against your own product. This page reproduces public FDA data for readability; EveryRecall is independent and not affiliated with the FDA.

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