Synergy Rx Recalls Tri-Bleaching Cream Due to Sterility Assurance Concerns
Synergy Rx is recalling Tri-Bleaching Cream because the product lacks assurance of sterility and has 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, and the hazard involves a lack of assurance of sterility in a prescription drug, which meets the criteria for a Severe rating.
Plain-English summary
Synergy Rx is recalling Tri-Bleaching Cream (Retinoic Acid 0.05%, Hydroquinone 8%, Fluocinolone 0.01%), a prescription-only product, due to a lack of assurance of sterility. The recall also cites Current Good Manufacturing Practice (CGMP) deviations.
The recall covers all lots of the product. Distribution was nationwide within the United States.
Consumers should stop using the product and contact their healthcare provider or the recalling firm for instructions on return or disposal.
The recalled product
- Product
- TRI-BLEACHING CREAM (Retinoic Acid 0.05%, Hydroquinone 8%, Fluocinolone 0.01%), 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 →Related recalls
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