The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0572-2017·Announced 2017-03-22

Synergy Rx Supreme Cream Recalled for Sterility Assurance Issues

Synergy Rx is recalling Supreme Cream due to a lack of assurance of sterility and CGMP deviations.

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 recall is classified as FDA Class II, which corresponds to a Severe rating under the rubric, particularly given the sterility concerns for a topical product.

Plain-English summary

Synergy Rx is recalling Supreme Cream, a prescription topical medication containing retinoic acid, hydroquinone, kojic acid, Alpha Arbutin, and Azelaic acid. The recall is being conducted because of a lack of assurance of sterility and Current Good Manufacturing Practice (CGMP) deviations.

The affected product is distributed nationwide within the United States. All lots of the product are included in this recall. The source text does not specify the number of units affected or report any specific illnesses or injuries.

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

The recalled product

Product
SUPREME CREAM (Retinoic acid 0.05%, hydroquinone 6%, kojic acid 3%, Alpha Arbutin otc 2%, Azeliac acid 2%), 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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