KRS Global Biotechnology Recalls Sterile Ophthalmic Solution Due to Sterility Concerns
KRS Global Biotechnology is recalling 649 droptainers of a sterile ophthalmic solution because the company cannot ensure the product's 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 sterile ophthalmic product where lack of sterility assurance 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 649 droptainers of Cyclopentolate HCl 1% / Phenylephrine HCl 2.5% / Tropicamide 1% / Ketorolac Tromethamine 0.5% Sterile Ophthalmic Topical Solution. The recall is being conducted because the company lacks assurance of the product's sterility.
The affected product is a prescription-only ophthalmic solution distributed nationwide. The recall includes all lots remaining within their expiry dates. The product is identified by NDC 3321676225.
Consumers and healthcare providers should stop using the recalled product and contact their healthcare provider or the manufacturer for further instructions.
The recalled product
- Product
- Cyclopentolate HCl 1% (10 mg/mL) / Phenylephrine HCl 2.5% (25 mg/mL) / Tropicamide 1% (10 mg/mL) / Ketorolac Tromethamine 0.5% (5 mg/mL), 3 mL Droptainer, Sterile Ophthalmic Topical Solution, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC…
- Manufacturer
- KRS Global Biotechnology, Inc
- Category
- Drug — Ophthalmic Solution
- Hazard
- Affected units
- 649
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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