KRS Global Biotechnology Recalls Phenylephrine Syringes Due to Sterility Concerns
KRS Global Biotechnology is recalling 15,260 syringes of Phenylephrine HCl injection nationwide due to a lack of assurance of sterility.
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, FDA Class II recalls involving significant injury or property damage reports, or structural defects, are rated as Severe (4). While no injuries are reported, the lack of sterility assurance in an injectable drug presents a significant risk.
Plain-English summary
KRS Global Biotechnology, Inc. is recalling 15,260 syringes of PHENYLephrine HCl in 0.9% Sodium Chloride (PF), 1 mg / 10 mL (0.1 mg/mL), 10 mL Fill in a 12 mL Single Dose Syringe Injection. The product is identified by NDC 3321677379 and is distributed nationwide.
The recall was initiated due to a lack of assurance of sterility. The source text does not specify which lots are affected, but indicates that all lots remaining within expiry are included. The source does not report any illnesses or injuries associated with this recall.
Healthcare providers and consumers should stop using the recalled product and contact KRS Global Biotechnology for further instructions or a refund.
The recalled product
- Product
- PHENYLephrine HCl in 0.9% Sodium Chloride (PF), 1 mg / 10 mL (0.1 mg/mL), 10 mL Fill in a 12 mL Single Dose Syringe Injection, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321677379
- Manufacturer
- KRS Global Biotechnology, Inc
- Category
- Drug — Injectable
- Hazard
- Affected units
- 15,260
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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