The Recall Desk
SevereFDA (Drugs)·D-0559-2017·Announced 2017-03-22

Synergy Rx Recalls Gentle Bleaching Cream Due to Sterility Concerns

Synergy Rx is recalling Gentle Bleaching Cream because the product lacks assurance of sterility and has 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 recall is classified as FDA Class II, which corresponds to a Severe severity score under the rubric for significant injury or property damage reports or high-risk conditions.

Plain-English summary

Synergy Rx is recalling Gentle Bleaching Cream (Retinoic Acid 0.025, Kojic Acid 3%, Hydrocortisone 1%), a prescription-only product. The recall was initiated due to a lack of assurance of sterility and Current Good Manufacturing Practice (CGMP) deviations.

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

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

The recalled product

Product
GENTLE BLEACHING CREAM (Retinoic Acid 0.025, 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 Cream
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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