Synergy Rx Recalls Melatonin Spray Due to Sterility Assurance Concerns
Synergy Rx is recalling Melatonin 1.5mg Spray 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 involves a risk-of-harm product (sterility failure) where injury has not yet been reported, which aligns with the High severity criteria.
Plain-English summary
Synergy Rx is recalling Melatonin 1.5mg Spray, a prescription-only product, due to a lack of assurance of sterility. The recall also cites Current Good Manufacturing Practice (CGMP) deviations associated with the product.
The recall covers all lots of the product. Distribution was nationwide within the United States. The source text does not specify the number of units affected or report any illnesses or injuries.
Consumers with this product should contact Synergy Rx at (855) 792-6676 for instructions on how to proceed.
The recalled product
- Product
- MELATONIN 1.5MG SPRAY, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
- Manufacturer
- Synergy Rx
- Category
- Drug — Melatonin Spray
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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