KRS Global Biotechnology Recalls Glycopyrrolate Syringes Due to Sterility Concerns
KRS Global Biotechnology is recalling Glycopyrrolate single-dose syringes nationwide because the company cannot guarantee the product is sterile.
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. According to the rubric, FDA Class II recalls involving significant injury/property-damage reports or hospitalization are rated as Severe (4). While specific injury reports are not detailed in the text, the 'lack of assurance of sterility' for an injectable drug represents a significant risk of infection, aligning with the Severe classification for Class II drug recalls.
Plain-English summary
KRS Global Biotechnology, Inc. is recalling 10,630 syringes of Glycopyrrolate (PF) 0.6 mg/3 mL (0.2 mg/mL) in 3 mL Single Dose Syringes. The product is prescription-only and was distributed nationwide. The recall covers all lots remaining within their expiration dates.
The recall was initiated due to a lack of assurance of sterility. This means the manufacturer cannot confirm that the syringes are free from microbial contamination. The FDA has classified this recall as Class II, indicating that use of the product could cause temporary or medically reversible adverse health consequences.
Healthcare providers and patients who have this product should stop using it and contact KRS Global Biotechnology for instructions on how to return or dispose of the syringes.
The recalled product
- Product
- GLYCOpyrrolate (PF) 0.6 mg/3 mL (0.2 mg/mL) in 3 mL Single Dose Syringe, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC3321678316
- Manufacturer
- KRS Global Biotechnology, Inc
- Category
- Drug — Injectable
- Affected units
- 10,630
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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