Synergy Rx Recalls HI-LITE Cream Due to Sterility Assurance Concerns
Synergy Rx is recalling HI-LITE Cream because the product lacks assurance of sterility and has 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 recall is classified as FDA Class II, which corresponds to a Severe severity score per the rubric for significant injury or property damage reports or high-risk conditions.
Plain-English summary
Synergy Rx is recalling HI-LITE Cream (Retinoic Acid 0.05%, Hydroquinone 4%, Fluocinolone 0.01%), a prescription-only topical medication. The recall is being conducted because the product lacks assurance of sterility and has Current Good Manufacturing Practice (CGMP) deviations.
The recall covers all lots of the product. The medication was distributed nationwide within the United States.
Consumers with this product should stop using it and contact their healthcare provider or the recalling firm for further instructions.
The recalled product
- Product
- HI-LITE Cream (Retinoic Acid 0.05%, Hydroquinone 4%, Fluocinolone 0.01%), 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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