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.
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. 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 →- SevereAvKare Carboxymethylcellulose Sodium Eye Drops Recalled for Sterility Concerns
FDA (Drugs) · 2026-09-30
- SevereAvKare Carboxymethylcellulose Sodium Eye Drops Recalled for Sterility Concerns
FDA (Drugs) · 2026-09-30
- 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
- SevereOne-Piece Introducer Tray kits recalled for sterility failure
FDA (Devices) · 2026-07-22
Similar recalls
- ModerateKRS Global Biotechnology Recalls Vitamin 9 A/B Lyophilized Vials Due to Labeling Errors
FDA (Drugs) · 2018-01-17
- ModerateKRS Global Biotechnology Recalls Vitamin 9 Vials Due to Labeling Errors
FDA (Drugs) · 2018-01-17
- ModerateKRS Global Biotechnology Recalls Vitamin 10 B Vials Due to Labeling Errors
FDA (Drugs) · 2018-01-17
- ModerateKRS Global Biotechnology Recalls Sincalide Vials Due to Labeling Errors
FDA (Drugs) · 2018-01-17
- ModerateKRS Global Biotechnology Recalls Topical Cream Due to Expired Ingredient
FDA (Drugs) · 2018-01-17
- ModerateKRS Global Biotechnology Recalls QUADMIX #17 Due to Expired Ingredients
FDA (Drugs) · 2018-01-17