Synergy Rx Recalls Retinoic Acid Products Due to Sterility Concerns
Synergy Rx is recalling various retinoic acid products 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, which corresponds to a Severe severity score under the rubric, particularly given the risk of infection associated with non-sterile medical products.
Plain-English summary
Synergy Rx is recalling multiple retinoic acid products, including creams, gels, and powders, due to a lack of assurance of sterility. The recall also cites Current Good Manufacturing Practice (CGMP) deviations.
The affected products include Retinoic Acid in various strengths (0.025%, 0.05%, and 0.1%) in cream form, as well as combination products with Clindamycin and Hyaluronic Acid. The recall covers all lots of these products.
These products were distributed nationwide within the United States. Consumers should stop using these products and contact their healthcare provider or the recalling firm for further instructions.
The recalled product
- Product
- RETINOIC ACID all strengths including 0.025%, 0.05% and 0.1% CREAM, RETINOIC ACID 0.025%/CLINDAMYCIN 1.2% GEL, RETINOIC ACID 0.025%/ HYALURONIC ACID CREAM, RETINOIC ACID 0.05%/HYALURONIC ACID CREAM, RETINOIC ACID 0.1% IN CERAVE CREAM, RETINOIC ACID POWDER 1 GRAM, RETINOIC…
- 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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