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.
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, 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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