Synergy Rx Recalls Fluorouracil Creams Due to Sterility Assurance Issues
Synergy Rx is recalling Fluorouracil creams 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 agency classification is FDA Class II, and the hazard involves a lack of assurance of sterility in a pharmaceutical product, which aligns with the 'Severe' criteria for significant potential harm.
Plain-English summary
Synergy Rx is recalling Fluorouracil products, including 5-Fluorouracil in Vanicream, Fluorouracil in all strengths (including 0.05% and 5% cream), and Fluorouracil 4.9% in CeraVe cream. The recall is being conducted because of a lack of assurance of sterility and Current Good Manufacturing Practice (CGMP) deviations.
The affected products were distributed nationwide within the United States. The recall covers all lots of the specified products.
Consumers should stop using the recalled products and contact their healthcare provider or pharmacist for guidance on next steps.
The recalled product
- Product
- 5-FLUOROURACIL IN VANICREAM, FLUOROURACIL in all strengths including 0.05%, 5% CREAM, FLUOROURACIL 4.9% IN CERAVE CREAM, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
- Manufacturer
- Synergy Rx
- Category
- Drug — Topical Antineoplastic
- 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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