KRS Global Biotechnology Recalls Glutathione Vials Due to Sterility Concerns
KRS Global Biotechnology is recalling 402 vials of Glutathione 30 mL due to a lack of assurance of sterility. The product was distributed nationwide.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (sterility issue in an injectable drug) where injury has not yet been reported, which aligns with the 'High' severity criteria in the rubric.
Plain-English summary
KRS Global Biotechnology, Inc is recalling 402 vials of Glutathione 30 mL Vial-For IM Use-Hypertonic solution, 6,000 mg/30 mL (200 mg/mL). The recall was initiated because of a lack of assurance of sterility. The affected product is identified by NDC 3321674186 and includes all lots remaining within expiry.
The recalled product was distributed nationwide. The source text does not specify a particular date range for the distribution or identify specific facilities where the product was sold.
Consumers and healthcare providers should stop using the affected product and contact their healthcare provider or the recalling firm for further instructions. The source text does not report any specific illnesses or injuries associated with this recall.
The recalled product
- Product
- Glutathione 30 mL Vial-For IM Use-Hypertonic solution, 6,000 mg/30 mL (200 mg/mL) Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC3321674186
- Manufacturer
- KRS Global Biotechnology, Inc
- Category
- Drug — Injectable
- Hazard
- Affected units
- 402
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 remaining within expiry.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 80 recalled by KRS Global Biotechnology, Inc 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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