KRS Global Biotechnology Recalls Phenylephrine and Lidocaine Ophthalmic Injection
KRS Global Biotechnology is recalling 3,150 vials of Phenylephrine HCl and Lidocaine Ophthalmic Injection 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, and the hazard of 'lack of assurance of sterility' in an ophthalmic injection poses a significant risk of serious injury or infection, meeting the criteria for a Severe rating.
Plain-English summary
KRS Global Biotechnology, Inc. is recalling 3,150 vials of Phenylephrine HCl 1.5% and Lidocaine 1% Ophthalmic Injection. The recall was initiated because of a lack of assurance of sterility in the product. The affected product is a prescription-only ophthalmic injection distributed nationwide.
The recall includes all lots of the product that remain within their expiration dates. The product is identified by NDC 3321678170 and is packaged as a 3 mL fill in a 5 mL single-dose syringe.
Healthcare providers and patients should stop using the recalled product and contact the manufacturer or their supplier for further instructions on returns or replacements.
The recalled product
- Product
- PHENYLephrine HCl 1.5% (15 mg/mL) LIDOcaine 1% (10 mg/mL) (PF) (Sulfite Free) Ophthalmic Injection, 3 mL fill in a 5 mL Single Dose Syringe, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678170
- Manufacturer
- KRS Global Biotechnology, Inc
- Category
- Drug — Ophthalmic Injection
- Affected units
- 3,150
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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