Synergy Rx Recalls Kojic Acid and Azelaic Acid Cream Due to Sterility Concerns
Synergy Rx is recalling Kojic Acid 8%/Azelaic Acid 15% Cream because it lacks assurance of sterility and has 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, which corresponds to a Severe rating under the rubric, particularly given the lack of assurance of sterility for a topical cream.
Plain-English summary
Synergy Rx is recalling Kojic Acid 8%/Azelaic Acid 15% Cream, a prescription-only product. The recall is being conducted because the product lacks assurance of sterility and the manufacturer has Current Good Manufacturing Practice (CGMP) deviations.
The recall covers all lots of the product. The distribution pattern is listed as nationwide within the United States.
Consumers should stop using the product and contact their healthcare provider or the recalling firm for instructions on disposal or return.
The recalled product
- Product
- KOJIC ACID 8%/AZELAIC ACID 15% CREAM, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
- Manufacturer
- Synergy Rx
- Category
- Drug — Topical Cream
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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