Synergy Rx Recalls Trichloroacetic Acid Solutions Due to Sterility Concerns
Synergy Rx is recalling Trichloroacetic Acid Solutions in various strengths due to a lack of assurance of sterility and 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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (sterility failure) where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Synergy Rx is recalling Trichloroacetic Acid Solution in all strengths, including 10%, 12%, 15%, 20%, 35%, 70%, and 85%, as well as Trichloroacetic Acid 10%/Lactic Acid 12% and Trichloroacetic Acid 6%/Lactic Acid 12%. The products are prescription-only and were distributed nationwide within the United States.
The recall was initiated due to a lack of assurance of sterility and Current Good Manufacturing Practice (CGMP) deviations. The source text does not specify the number of affected units or specific lot numbers, indicating that all lots are involved.
Consumers and healthcare providers should stop using these products and contact Synergy Rx at (855) 792-6676 or their healthcare provider for further instructions.
The recalled product
- Product
- TRICHLOROACETIC ACID SOLUTION in all strengths including: 10%, 12%, 15 %, 20%, 35%, 70%, and 85%, TRICHLOROCETIC ACID 10%/ LACTIC ACID 12%, TRICHLOROCETIC ACID 6%/LACTIC ACID 12%, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
- Manufacturer
- Synergy Rx
- Category
- Drug — Topical Solution
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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