KRS Global Biotechnology Recalls L-Asparaginase Lyophilized Due to Sterility Concerns
KRS Global Biotechnology is recalling L-Asparaginase Lyophilized because the agency cannot assure the product's sterility. The recall covers all lots remaining within their expiration dates.
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 involving significant injury/property-damage reports or hospitalization reports are rated as Severe (4). While the source does not explicitly state hospitalizations, the lack of sterility assurance for an injectable drug is a significant hazard that aligns with the Severe classification for Class II recalls involving potential serious harm.
Plain-English summary
KRS Global Biotechnology, Inc. is recalling L-Asparaginase Lyophilized, 10,000 International Units/Vial, For IV / IM / SC Use, Rx Only (NDC 3321674499). The recall was initiated because the company lacks assurance of the product's sterility.
The recall is classified as Class II by the U.S. Food and Drug Administration. It affects all lots of the product that are remaining within their expiration dates. The product was distributed nationwide.
Consumers and healthcare providers should stop using the recalled product and contact their healthcare provider or the manufacturer for further instructions. No specific illness or injury reports are mentioned in the source text.
The recalled product
- Product
- L-Asparaginase Lyophilized, 10,000 International Units/Vial, For IV / IM / SC Use, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321674499
- Manufacturer
- KRS Global Biotechnology, Inc
- Category
- Drug — Injectable Medication
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.
See all 80 products in this recall →Related recalls
Same manufacturer · KRS Global Biotechnology, Inc
See all →- SevereKRS Global Biotechnology Recalls Lidocaine HCl Syringes Due to Sterility Concerns
FDA (Drugs) · 2019-10-09
- SevereKRS Global Biotechnology Recalls Human Chorionic Gonadotropin Due to Sterility Concerns
FDA (Drugs) · 2019-10-09
- SevereFDA Recalls Phenylephrine IV Bags Due to Sterility Concerns
FDA (Drugs) · 2019-10-09
- ModerateSermorelin and GHRP-2 Lyophilized Vials Recalled Due to Sterility Concerns
FDA (Drugs) · 2019-10-09
- SevereKRS Global Biotechnology Recalls Phenylephrine IV Bags Due to Sterility Concerns
FDA (Drugs) · 2019-10-09
Same hazard · sterility failure
See all →- SevereROHTO DIGI-EYE Eye Drops Recalled Over Sterility Assurance Gap
FDA (Drugs) · 2026-07-29
- HighROHTO DRY-AID Eye Drops Recalled Due to Sterility Concerns
FDA (Drugs) · 2026-07-29
- SevereTransvenous Pacing Electrode Tray with Bipolar Balloon Pacing Electrode Recalled
FDA (Devices) · 2026-07-22
- SevereArterial Line Kit with Lidocaine HCL Injection Fails Sterility Testing
FDA (Devices) · 2026-07-22
- SevereOne-Piece Introducer Tray kits recalled for sterility failure
FDA (Devices) · 2026-07-22