The Recall Desk
HighFDA (Drugs)·D-0557-2017·Announced 2017-03-22

Synergy Rx Recalls Firm and Fade Cream Due to Sterility Concerns

Synergy Rx is recalling Firm and Fade cream because it may not be sterile. The recall covers all lots distributed nationwide.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a lack of sterility assurance for a prescription drug, which poses a risk of harm without reported injuries.

Plain-English summary

Synergy Rx is recalling Firm and Fade (Retinoic Acid 0.05%, Hydroquinone 6%, Kojic Acid 3%, Hydrocortisone 1%), a prescription-only topical medication. The recall is being conducted because the product lacks assurance of sterility and involves Current Good Manufacturing Practice (CGMP) deviations.

The recall includes all lots of the product. The medication was distributed nationwide within the United States.

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

The recalled product

Product
FIRM AND FADE (Retinoic Acid 0.05%, Hydroquinone 6%, Kojic Acid 3%, Hydrocortisone 1%), Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
Manufacturer
Synergy Rx
Category
Drug — Topical Prescription
Hazard

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 →

Related recalls

Same manufacturer · Synergy Rx

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Same hazard · sterility

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