Synergy Rx Recalls Hydrocortisone Cream Due to Sterility Assurance Issues
Synergy Rx is recalling Hydrocortisone 2.5% with Aloe Vera Cream because the product lacks assurance of sterility and has CGMP deviations.
What this means for you
Illness, injury, or structural failure has been reported. 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 prescription drug, which aligns with the 'Severe' criteria for significant risk.
Plain-English summary
Synergy Rx is recalling Hydrocortisone 2.5% with Aloe Vera Cream, a prescription-only product. The recall is being conducted because the product lacks assurance of sterility and 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 further instructions.
The recalled product
- Product
- HYDROCORTISONE 2.5% WITH ALOE VERA CREAM, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
- Manufacturer
- Synergy Rx
- Category
- Drug — Topical Steroid
- 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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