KRS Global Biotechnology Recalls Ophthalmic Solution Due to Sterility Concerns
KRS Global Biotechnology is recalling Cyclopentolate HCl, Phenylephrine HCl, and Tropicamide ophthalmic solution because the company cannot guarantee the product is sterile.
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 FDA classified this recall as Class II. According to the severity rubric, an FDA Class II recall involving a sterile ophthalmic product (where sterility failure implies significant risk of infection/injury) maps to a score of 4 (Severe), as it exceeds the threshold for 'High' (which typically applies to theoretical risks or specific pathogens without reported illness) and aligns with the 'significant injury' potential of non-sterile eye drops.
Plain-English summary
KRS Global Biotechnology, Inc. is recalling 242 droptainers of Cyclopentolate HCl 1% / Phenylephrine HCl 2.5% / Tropicamide 1% 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 with NDC 3321678092.
The recall covers all lots of the product that are remaining within their expiration dates. The product was distributed nationwide. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
Consumers and healthcare providers should stop using the recalled product and contact their healthcare provider or the recalling firm for further instructions. The source text does not report any specific illnesses or injuries associated with this recall.
The recalled product
- Product
- Cyclopentolate HCl 1% (10 mg/mL) / Phenylephrine HCl 2.5% (25 mg/mL) / Tropicamide 1% (10 mg/mL), Sterile Ophthalmic Topical Solution, 5 mL Fill in a 7 mL Droptainer, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678092
- Manufacturer
- KRS Global Biotechnology, Inc
- Category
- Drug — Ophthalmic
- Affected units
- 242
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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