Synergy Rx Recalls Topical Acne Medications Due to Sterility Concerns
Synergy Rx is recalling specific clindamycin and tretinoin products 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 agency classification is FDA Class II, and the source text explicitly cites a 'Lack of Assurance of Sterility' and CGMP deviations, which aligns with the rubric criteria for Severe severity involving significant risk factors.
Plain-English summary
Synergy Rx is recalling several prescription topical acne medications, including Clindamycin 1% / Azelaic Acid 10% Cream, Clindamycin 1.2% / Tretinoin 0.05% Gel, Clindamycin 1.2% / Tretinoin 0.1% Gel, and Clindamycin 2.5% / Benzoyl Peroxide 5%. The recall covers all lots of these products.
The recall was initiated because of a lack of assurance of sterility and Current Good Manufacturing Practice (CGMP) deviations. The products were distributed nationwide within the United States.
Consumers should stop using these products and contact their healthcare provider or pharmacist for further instructions.
The recalled product
- Product
- CLINDAMYCIN 1%, AZELAIC ACID 10% CREAM, CLINDAMYCIN 1.2%/ TRETINOIN 0.05% GEL, CLINDAMYCIN 1.2%/ TRETINOIN 0.1% GEL CLINDAMYCIN 2.5%, BENZOYL PEROXIDE 5%, 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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