KRS Global Biotechnology Recalls Ophthalmic Injection Due to Sterility Concerns
KRS Global Biotechnology is recalling Lidocaine/Bupivacaine/Hyaluronidase ophthalmic injections 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 agency classified this as an FDA Class II recall. Per the rubric, FDA Class II recalls involving significant injury/property-damage reports or hospitalization are Severe. While no injuries are reported, the lack of sterility assurance in an ophthalmic injection presents a significant risk of serious infection, aligning with the 'Severe' criteria for significant injury potential or high-risk contamination.
Plain-English summary
KRS Global Biotechnology, Inc. is recalling Lidocaine 2% / Bupivacaine 0.375% / Hyaluronidase 3 U/mL Ophthalmic Injection. The product is a prescription-only medication packaged in 5 mL fill in a 6 mL single-dose syringes. The recall affects 2,255 syringes distributed nationwide.
The recall was initiated due to a lack of assurance of sterility. This means the manufacturer cannot guarantee that the product is free from microbial contamination. The source text does not specify which lots are affected, but notes that all lots remaining within expiry are included.
Healthcare providers and patients who have received this product should contact their healthcare provider for guidance. The source text does not provide specific instructions for disposal or return, nor does it report any illnesses or injuries associated with the use of this product.
The recalled product
- Product
- LIDOcaine 2% (20 mg/mL)/Bupivacaine 0.375% (3.75 mg/mL)/ Hyaluronidase 3 U/mL (PF) Ophthalmic Injection, 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 3321678362
- Manufacturer
- KRS Global Biotechnology, Inc
- Category
- Drug — Ophthalmic Injection
- Affected units
- 2,255
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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