KRS Global Biotechnology Recalls Ophthalmic Syringes Due to Sterility Concerns
KRS Global Biotechnology is recalling 465 syringes of a sterile ophthalmic solution because the company cannot guarantee 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 the hazard involves a lack of assurance of sterility in a sterile ophthalmic product, which poses a significant risk of infection or injury.
Plain-English summary
KRS Global Biotechnology, Inc. is recalling 465 syringes 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 medication distributed nationwide, and the recall includes all lots remaining within their expiration dates.
Consumers and healthcare providers who have this product should stop using it and contact their healthcare provider or the recalling firm for further instructions. The product is identified by NDC 3321677124 and is manufactured by KRS Global Biotechnology, Inc. in Boca Raton, Florida.
The recalled product
- Product
- Cyclopentolate HCl 1% (5 mg/0.5 mL) / Phenylephrine HCl 2.5% (12.5 mg/0.5 mL) / Tropicamide 1% (5 mg/0.5 mL), 0.5 mL Fill in a 3 mL Syringe, Sterile Ophthalmic Topical Solution, (Contains Sulfites), Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL…
- Manufacturer
- KRS Global Biotechnology, Inc
- Category
- Drug — Ophthalmic
- Hazard
- Affected units
- 465
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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