Synergy Rx Bleaching Cream Recalled for Sterility Assurance Issues
Synergy Rx is recalling Bleaching Cream products 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 agency classification is FDA Class II, and the hazard involves a lack of assurance of sterility, which aligns with the rubric criteria for Severe severity.
Plain-English summary
Synergy Rx is recalling Bleaching Cream 0.1% Cream, Bleaching Cream HQ4%, and Bleaching Cream-NO HQ. The recall is due to a lack of assurance of sterility and Current Good Manufacturing Practice (CGMP) deviations.
The affected products are prescription-only and were distributed nationwide within the United States. All lots are included in this recall.
Consumers should stop using these products and contact their healthcare provider or the recalling firm for further instructions.
The recalled product
- Product
- BLEACHING CREAM 0.1% CREAM, BLEACHING CREAM HQ4%, BLEACHING CREAM-NO HQ, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
- Manufacturer
- Synergy Rx
- Category
- Drug — Topical Sterilization
- 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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