The Recall Desk
SevereFDA (Drugs)·D-0599-2017·Announced 2017-03-22

Synergy Rx Custom Lightening Cream Recalled for Sterility Assurance Issues

Synergy Rx is recalling Custom Lightening/Brightening Cream due to lack of assurance of sterility and CGMP deviations.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classification is FDA Class II, which corresponds to a Severe severity score per the rubric.

Plain-English summary

Synergy Rx is recalling Custom Lightening/Brightening Cream, a prescription-only product, due to a lack of assurance of sterility. The recall also cites Current Good Manufacturing Practice (CGMP) deviations.

The product was distributed nationwide within the United States. All lots are affected by this recall.

Consumers should stop using the product and contact their healthcare provider or the recalling firm for further instructions.

The recalled product

Product
CUSTOM LIGHTENING/BRIGHTENING CREAM, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
Manufacturer
Synergy Rx

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • All Lots

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 81 recalled by Synergy Rx under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 81 products in this recall →