KRS Global Biotechnology Recalls ePHEDrine Sulfate Syringes Due to Sterility Concerns
KRS Global Biotechnology is recalling ePHEDrine Sulfate 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 recall is classified as FDA Class II. According to the rubric, FDA Class II recalls involving significant injury/property-damage reports or hospitalization are rated Severe. While no specific injuries are reported in the text, the lack of sterility assurance in an injectable drug presents a significant risk of serious harm, aligning with the Severe classification for Class II recalls with potential for significant injury.
Plain-English summary
KRS Global Biotechnology, Inc. is recalling 16,585 syringes of ePHEDrine Sulfate in 0.9% Sodium Chloride (PF) 50 mg/10 mL (5 mg/mL) 10 mL Fill in a 12 mL Single Dose Syringe. The product is prescription-only and is identified by NDC 3321678373. The recall covers all lots remaining within their expiration dates.
The recall was initiated due to a lack of assurance of sterility. The affected products were distributed nationwide. The source text does not report any specific illnesses, injuries, or deaths associated with the use of these syringes.
Healthcare providers and patients should stop using the recalled syringes and contact the manufacturer or their supplier for further instructions on returns or replacements.
The recalled product
- Product
- ePHEDrine Sulfate in 0.9% Sodium Chloride (PF) 50 mg/10 mL (5 mg/mL) 10 mL Fill in a 12 mL Single Dose Syringe, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678373
- Manufacturer
- KRS Global Biotechnology, Inc
- Category
- Drug — Injectable
- Hazard
- Affected units
- 16,585
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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