Synergy Rx Recalls Diclofenac Lip Balm Due to Sterility Concerns
Synergy Rx is recalling Diclofenac Lip Balm products because they may not be sterile. The recall covers all lots distributed nationwide.
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 recall is classified as FDA Class II, which corresponds to a Severe rating under the rubric, particularly given the risk of infection associated with non-sterile medical products.
Plain-English summary
Synergy Rx is recalling Diclofenac 3% and 5% Lip Balm and Diclofenac 5% SPF 30 Lip Balm. The recall is due to a lack of assurance of sterility and Current Good Manufacturing Practice (CGMP) deviations.
The affected products are prescription-only and were distributed nationwide within the United States. The recall includes all lots of the product.
Consumers should stop using the product and contact their healthcare provider or the recalling firm for instructions on how to return or dispose of the medication.
The recalled product
- Product
- DICLOFENAC 3% and 5% LIP BALM and DICLOFENAC 5% SPF 30 LIP BALM, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
- Manufacturer
- Synergy Rx
- Category
- Drug — Topical Prescription
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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