Recalls / Class II

Class IID-0548-2017

Product

HYDROQUINONE SOLUTION in all strengths including 4%, 28%, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676

Affected lot / code info

All Lots

Why it was recalled

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

Recalling firm

Firm

Synergy Rx

Notification channel

Telephone

Type

Voluntary: Firm initiated

Address

4901 Morena Blvd Ste 504A, N/A, San Diego, California 92117-7310

Distribution

Quantity

N/A

Distribution pattern

Nationwide within the United States

Timeline

Recall initiated

2017-02-10

FDA classified

2017-03-15

Posted by FDA

2017-03-22

Terminated

2017-05-23

Status

Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-0548-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.