The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0556-2017·Announced 2017-03-22

Synergy Rx Recalls DUO Cream Due to Sterility Assurance Concerns

Synergy Rx is recalling DUO Cream because the product lacks assurance of sterility and has CGMP deviations. The recall covers all lots distributed nationwide.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The FDA classified this as a Class II recall. According to the rubric, an FDA Class II recall with potential for adverse health consequences (lack of sterility assurance) corresponds to a Severe severity score of 4.

Plain-English summary

Synergy Rx is recalling DUO Cream, a prescription topical medication containing Retinoic Acid 0.05%, Hydroquinone 6%, Kojic Acid 3%, and Hydrocortisone 0.1%. The recall was initiated because the product lacks assurance of sterility and is associated with Current Good Manufacturing Practice (CGMP) deviations.

The recall includes all lots of the product. Distribution was nationwide within the United States. The FDA has classified this recall as Class II, indicating a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

Consumers who have DUO Cream should stop using it and contact their healthcare provider or pharmacist for guidance on disposal or replacement. The recalling firm is Synergy Rx, located in San Diego, California.

The recalled product

Product
DUO Cream (Retinoic Acid 0.05%, Hydroquinone 6%, Kojic Acid 3%, Hydrocortisone 0.1%), 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 →

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