Synergy Rx Recalls RETIN-A 0.05% Cream Due to Sterility Concerns
Synergy Rx is recalling RETIN-A 0.05% Cream because of 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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II and involves CGMP deviations and sterility assurance issues, which aligns with the criteria for moderate severity involving low-risk contamination or voluntary precautionary measures without reported injuries.
Plain-English summary
Synergy Rx is recalling RETIN-A 0.05% Cream, a prescription-only medication. The recall is being conducted due to a lack of assurance of sterility and Current Good Manufacturing Practice (CGMP) deviations.
The affected product is distributed nationwide within the United States. The recall applies to all lots of the product.
Consumers with this product should stop using it and contact their healthcare provider or the recalling firm for further instructions.
The recalled product
- Product
- RETIN-A 0.05% CREAM, 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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