FDA Recalls Sterile Compounded Glutathione Products Due to Sterility Concerns
Natures Pharmacy & Compounding Center is recalling all lots of sterile compounded products due to quality control issues affecting sterility assurance.
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. According to the rubric, FDA Class II recalls with potential for adverse health consequences (such as sterility failures in sterile products) align with a score of 4 (Severe), as they are not Class I but involve significant risk.
Plain-English summary
The U.S. Food and Drug Administration (FDA) has issued a recall for sterile products compounded by Natures Pharmacy & Compounding Center. The recall includes all lots of sterile products that are not expired. The specific product identified in the recall notice is Glutathione 1.25%/Ascorbic 1.25%/DMSO 6.25%.
The recall was initiated due to a lack of sterility assurance. During a recent FDA inspection, quality control procedures were observed that present a potential risk to the sterility of the compounded products. This classification is designated as FDA Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
Consumers and healthcare providers who have purchased or received these sterile compounded products should stop using them and contact their healthcare provider or the recalling firm for further instructions. The distribution pattern is listed as NC (North Carolina).
The recalled product
- Product
- Glutathione 1.25%/Ascorbic 1.25%/DMSO 6.25%
- Manufacturer
- Natures Pharmacy & Compounding Center
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 lot numbers within expiry.
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 48 recalled by Natures Pharmacy & Compounding Center 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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