The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0551-2017·Announced 2017-03-22

Synergy Rx Brightening Cream Recalled for Sterility Assurance Issues

Synergy Rx is recalling Brightening Cream due to a lack of assurance of sterility and CGMP deviations. The product is 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 agency classification is FDA Class II, and the source text explicitly cites 'Lack of Assurance of Sterility' and 'CGMP Deviations.' Under the rubric, FDA Class II recalls involving sterility assurance issues are classified as Severe (Score 4).

Plain-English summary

Synergy Rx is recalling Brightening Cream, a prescription-only product containing retinoic acid, hydroquinone, kojic acid, and hydrocortisone. The recall is being conducted because of a lack of assurance of sterility and Current Good Manufacturing Practice (CGMP) deviations.

The product is distributed nationwide within the United States. The recall covers all lots of the product.

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

The recalled product

Product
BRIGHTENING CREAM (Retinoic acid 0.1%, Hydroquinone 4%, 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 →

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