The Recall Desk
SevereFDA (Drugs)·D-0548-2017·Announced 2017-03-22

Synergy Rx Recalls Hydroquinone Solution Due to Sterility Concerns

Synergy Rx is recalling Hydroquinone Solution in all strengths due to a 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 recall is classified as FDA Class II, which corresponds to a Severe severity score under the rubric, particularly given the risk of infection associated with sterility issues in pharmaceutical products.

Plain-English summary

Synergy Rx is recalling Hydroquinone Solution in all strengths, including 4% and 28%, which are prescription-only products. The recall is being conducted because of a lack of assurance of sterility and Current Good Manufacturing Practice (CGMP) deviations.

The affected products were distributed nationwide within the United States. The recall includes all lots of the product.

Consumers who have this product should stop using it and contact their healthcare provider or pharmacist for further instructions.

The recalled product

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
Manufacturer
Synergy Rx
Category
Drug — Topical Solution
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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