Synergy Rx Recalls Metronidazole and Azelaic Acid Products for Sterility Concerns
Synergy Rx is recalling Metronidazole 1% Gel and Metronidazole/Niacinamide/Azelaic Cream due to lack of assurance of sterility and CGMP deviations.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the source text does not report any illnesses, injuries, or hospitalizations, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Synergy Rx is voluntarily recalling Metronidazole 1% Gel and Metronidazole 1%/Niacinamide 4%/Azelaic Cream 10% Cream. The recall is being conducted because of a lack of assurance of sterility and Current Good Manufacturing Practice (CGMP) deviations.
The affected products are prescription-only medications distributed nationwide within the United States. The recall covers all lots of these specific products.
Consumers and healthcare providers should stop using the recalled products and contact their healthcare provider or pharmacist for further instructions. Synergy Rx can be reached at (855) 792-6676 for additional information.
The recalled product
- Product
- METRONIDAZOLE 1% GEL, METRONIDAZOLE 1%/ NIACINAMIDE 4%/ AZELAIC CREAM 10% CREAM, 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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