KRS Global Biotechnology Recalls Ephedrine Sulfate Syringes Due to Sterility Concerns
KRS Global Biotechnology is recalling 3,895 syringes of ephedrine sulfate due to a lack of assurance of sterility. The product was distributed nationwide.
What this means for you
Illness, injury, or structural failure has been reported. 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, an FDA Class II recall involving a significant risk such as a lack of assurance of sterility in an injectable drug corresponds to a severity score of 4 (Severe).
Plain-English summary
KRS Global Biotechnology, Inc. is recalling 3,895 syringes of ePHEDrine Sulfate in 0.9% Sodium Chloride (PF), 50 mg/5 mL (10 mg/mL). The product is packaged as a 5 mL fill in a 6 mL single-dose syringe. The recall is being conducted because of a lack of assurance of sterility.
The affected product is identified by NDC 3321678375. The recall covers all lots remaining within their expiry dates. The product was distributed nationwide.
Consumers and healthcare providers should stop using the recalled product and contact KRS Global Biotechnology, Inc. for further instructions or a return.
The recalled product
- Product
- ePHEDrine Sulfate in 0.9% Sodium Chloride (PF), 50 mg/5 mL (10 mg/mL) 5 mL Fill in a 6 mL Syringe, Single Dose Syringe. KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678375
- Manufacturer
- KRS Global Biotechnology, Inc
- Category
- Drug — Injectable
- Affected units
- 3,895
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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