Synergy Rx Recalls Tretinoin Cream and Gel Due to Sterility Concerns
Synergy Rx is recalling Tretinoin Cream and Gel in all strengths due to a lack of assurance of sterility and 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 is classified as FDA Class II, and the hazard involves a lack of assurance of sterility, which poses a risk of harm where injury has not yet been reported.
Plain-English summary
Synergy Rx is recalling Tretinoin Cream and Tretinoin Gel in all strengths, including 0.1% and 0.05%. The products are prescription-only and were 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. The source text does not specify particular lot numbers, stating that all lots are affected.
Consumers with these products should stop using them and contact their healthcare provider or the recalling firm for further instructions.
The recalled product
- Product
- TRETINOIN CREAM in all strengths including: 0.1%, 0.05%, TRETINOIN GEL in all strengths including 0.1% and 0.05%, 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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