KRS Global Biotechnology Recalls Phenylephrine and Lidocaine Ophthalmic Injection
KRS Global Biotechnology is recalling 825 syringes of Phenylephrine 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 involves a lack of assurance of sterility in an ophthalmic injection, which poses a significant risk of serious injury or infection.
Plain-English summary
KRS Global Biotechnology, Inc. is recalling 825 single-dose syringes of Phenylephrine HCl 1.5% and Lidocaine HCl 1% Ophthalmic Injection. The recall is being conducted because of a lack of assurance of sterility. The affected product is distributed nationwide and includes all lots remaining within their expiration dates.
The recalled product is a prescription-only ophthalmic injection intended for use in the eye. The specific NDC number for the recalled product is 3321678441. The recall is classified as Class II by the U.S. Food and Drug Administration.
Healthcare providers and patients who have this product should stop using it and contact their healthcare provider or the manufacturer for further instructions. Consumers should not use the product if they have received it.
The recalled product
- Product
- Phenylephrine HCl 1.5% (15 mg/mL) Lidocaine HCl 1% (10 mg/mL) (PF) (Sulfite Free) Ophthalmic Injection, 3 mL Single Dose Syringe, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678441
- Manufacturer
- KRS Global Biotechnology, Inc
- Category
- Drug — Ophthalmic Injection
- Affected units
- 825
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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