KRS Global Biotechnology Recalls Neostigmine Methylsulfate Syringes for Sterility Concerns
KRS Global Biotechnology is recalling Neostigmine Methylsulfate syringes due to a lack of assurance of sterility. The recall covers 3,410 syringes 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 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 or property damage reports, or in this case a critical sterility failure in an injectable drug, warrant a score of 4 (Severe).
Plain-English summary
KRS Global Biotechnology, Inc. is recalling Neostigmine Methylsulfate (PF), 5 mg/5 mL (1 mg/mL), 5 mL fill in a 6 mL Single Dose Syringe. The recall was initiated because of a lack of assurance of sterility. The affected product is identified by NDC 3321678303.
The recall involves 3,410 syringes that were distributed nationwide. All lots remaining within their expiration dates are affected. The product is prescription-only.
Consumers and healthcare providers should stop using the recalled product and contact their healthcare provider or the recalling firm for further instructions.
The recalled product
- Product
- NEOstigmine Methylsulfate (PF), 5 mg/5 mL (1 mg/mL), 5 mL fill in a 6 mL Single Dose Syringe, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678303
- Manufacturer
- KRS Global Biotechnology, Inc
- Category
- Drug — Injectable
- Hazard
- Affected units
- 3,410
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
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