Synergy Rx Recalls Minoxidil Products Due to Sterility Assurance Concerns
Synergy Rx is recalling Minoxidil and Minoxidil/Retinoic Acid products nationwide due to a lack of assurance of sterility and CGMP deviations.
What this means for you
Illness, injury, or structural failure has been reported. 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, which corresponds to a 'Severe' severity score under the rubric for significant potential health risks such as sterility failures in pharmaceutical products.
Plain-English summary
Synergy Rx is voluntarily recalling all strengths of Minoxidil, including 2% and 5%, as well as Minoxidil/Retinoic Acid 5%/0.025 products. The recall covers all lots of these products distributed nationwide within the United States.
The recall was initiated because of a lack of assurance of sterility and Current Good Manufacturing Practice (CGMP) deviations. These issues indicate that the manufacturing process may not have consistently ensured the products were sterile as required.
Consumers who have purchased these products should stop using them and contact Synergy Rx for further instructions or a refund. The company can be reached at (855) 792-6676 or at their address in San Diego, California.
The recalled product
- Product
- MINOXADIL all strength including 2%, 5% and MINOXIDIL / RETINOIC ACID 5% / 0.025, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
- Manufacturer
- Synergy Rx
- Category
- Drug — Topical Medication
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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