Synergy Rx Recalls Clobetasol Products Due to Sterility Assurance Concerns
Synergy Rx is recalling Clobetasol 0.05% products because the FDA identified 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 sterility failure in pharmaceutical products.
Plain-English summary
Synergy Rx is recalling Clobetasol 0.05% in Olea Base, Clobetasol 0.05% in Orobase, Clobetasol 0.05% Ointment, and Clobetasol 0.05%/Sodium Sulfacetamide 10% Cream. The recall covers all lots of these prescription-only products, which were distributed nationwide within the United States.
The recall was initiated due to a lack of assurance of sterility and Current Good Manufacturing Practice (CGMP) deviations identified by the FDA. These issues raise concerns about the safety and quality of the sterile pharmaceutical products.
Consumers and healthcare providers with these products should stop using them and contact Synergy Rx at (855) 792-6676 for instructions on how to return the products.
The recalled product
- Product
- CLOBETASOL 0.05% IN OLEA BASE, CLOBETASOL 0.05% IN OROBASE, CLOBETASOL 0.05% OINTMENT, CLOBETASOL 0.05%/ SODIUM, SULFACETAMIDE 10% CREAM, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
- Manufacturer
- Synergy Rx
- Category
- Drug — Topical Steroid
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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