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.
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 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
- 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.
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