The Recall Desk
HighFDA (Drugs)·D-0575-2017·Announced 2017-03-22

Synergy Rx Recalls TRI-BLEACHING CREAM Due to Sterility Assurance Issues

Synergy Rx is recalling TRI-BLEACHING CREAM because it lacks assurance of sterility and has CGMP deviations. The product is 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 involves a risk-of-harm product (sterility issues) where injury has not yet been reported, meeting the criteria for a High severity score.

Plain-English summary

Synergy Rx is recalling TRI-BLEACHING CREAM (Retinoic Acid 0.1%, Hydroquinone 4%, Fluocinolone 0.01%), a prescription-only product. The recall is due to a lack of assurance of sterility and Current Good Manufacturing Practice (CGMP) deviations.

The product is 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
TRI-BLEACHING CREAM (Retinoic Acid 0.1%, Hydroquinone 4%, Fluocinolone 0.01%), 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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