Synergy Rx Recalls Reverse DML Lotion Due to Sterility Assurance Issues
Synergy Rx is recalling all lots of Reverse DML Lotion because the product lacks assurance of sterility and has CGMP deviations.
What this means for you
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 is classified as FDA Class II and involves a risk-of-harm product (lack of sterility assurance) where specific injury reports are not detailed in the source text, fitting the 'High' severity criteria for theoretical or unreported harm risks.
Plain-English summary
Synergy Rx is recalling all lots of Reverse DML Lotion, a prescription-only topical medication containing Ketoconazole 2%, Metronidazole 2%, and sulfacetamide sodium 10%. The recall was initiated because the product lacks assurance of sterility and is associated with Current Good Manufacturing Practice (CGMP) deviations.
The affected product was distributed nationwide within the United States. The recall covers all lots of the medication.
Consumers and healthcare providers should stop using the recalled product and contact their healthcare provider or the recalling firm for further instructions.
The recalled product
- Product
- REVERSE DML LOTION (Ketoconazole 2%, Metronidazole 2%, sulfacetamide sodium 10%), 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.
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