KRS Global Biotechnology Recalls Neostigmine Methylsulfate Syringes for Sterility Concerns
KRS Global Biotechnology is recalling 7,685 vials of Neostigmine Methylsulfate due to a lack of assurance of sterility. The recall is 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 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 FDA classified this as a Class II recall, and the hazard involves a lack of assurance of sterility in a parenteral product, which carries a risk of serious injury or infection.
Plain-English summary
KRS Global Biotechnology, Inc. is recalling 7,685 single-dose syringes of Neostigmine Methylsulfate (PF), 3 mg/3 mL (1 mg/mL). The product is identified by NDC 3321677847. The recall is being conducted because of a lack of assurance of sterility.
The affected product was distributed nationwide. The recall includes all lots remaining within their expiry dates. The FDA has classified this recall as Class II.
Healthcare providers and patients should stop using the recalled product and contact their healthcare provider for further instructions. Consumers should not use the product if they have it in their possession.
The recalled product
- Product
- NEOstigmine Methylsulfate (PF), 3 mg/3 mL (1 mg/mL), 3 mL Single Dose Syringe, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321677847
- Manufacturer
- KRS Global Biotechnology, Inc
- Category
- Drug — Injectable
- Affected units
- 7,685
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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