PlainRecalls
FDA Drug Moderate Class II Terminated

METRONIDAZOLE 1% GEL, METRONIDAZOLE 1%/ NIACINAMIDE 4%/ AZELAIC CREAM 10% CREAM, 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-0595-2017

Product Description

METRONIDAZOLE 1% GEL, METRONIDAZOLE 1%/ NIACINAMIDE 4%/ AZELAIC CREAM 10% 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.

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?
METRONIDAZOLE 1% GEL, METRONIDAZOLE 1%/ NIACINAMIDE 4%/ AZELAIC CREAM 10% CREAM, 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-0595-2017.