KRS Global Biotechnology Recalls Alpha Lipoic Acid Vials Due to Sterility Concerns
KRS Global Biotechnology is recalling 77 vials of Alpha Lipoic Acid for IV use nationwide due to a lack of assurance of sterility.
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 and involves a lack of assurance of sterility in an intravenous product, which poses a significant risk of serious injury or hospitalization.
Plain-English summary
KRS Global Biotechnology, Inc. is recalling 77 vials of Alpha Lipoic Acid (PF) 750 mg/30 mL (25 mg/mL) 30 mL Single Dose Vials for IV Use. The product is prescription-only and was distributed nationwide. The recall is being conducted due to a lack of assurance of sterility.
The affected product is identified by NDC 3321674205. The recall includes all lots remaining within their expiry dates. The manufacturer is located in Boca Raton, Florida.
Healthcare providers and patients should stop using the affected vials and contact the manufacturer or their healthcare provider for further instructions. Consumers should not use the product if they have questions about its safety.
The recalled product
- Product
- Alpha Lipoic Acid (PF) 750 mg/30 mL (25 mg/mL) 30 mL Single Dose Vial for IV Use, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321674205
- Manufacturer
- KRS Global Biotechnology, Inc
- Category
- Drug — Intravenous Solution
- Affected units
- 77
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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