Synergy Rx Recalls CLEAR Gel Due to Sterility Assurance Concerns
Synergy Rx is recalling all lots of CLEAR (Benzoyl Peroxide 3.75%, Clindamycin 1.2% Gel) due to a lack of assurance of sterility and CGMP deviations.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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. According to the rubric, an FDA Class II recall involving a structural or manufacturing defect (lack of sterility assurance) that poses a significant risk of harm is classified as Severe.
Plain-English summary
Synergy Rx is voluntarily recalling all lots of CLEAR (Benzoyl Peroxide 3.75%, Clindamycin 1.2% Gel), a prescription-only topical medication. The recall was initiated because of a lack of assurance of sterility and identified Current Good Manufacturing Practice (CGMP) deviations.
The product was distributed nationwide within the United States. The source text does not specify a particular quantity of units affected or a specific distribution date range.
Consumers with this product should stop using it and contact their healthcare provider or the recalling firm for further instructions.
The recalled product
- Product
- CLEAR (Benzoyl Peroxide 3.75%, Clindamycin 1.2% Gel), 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.
See all 81 products in this recall →Related recalls
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