The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0106-2020·Announced 2019-10-09

KRS Global Biotechnology Recalls Sterile Ophthalmic Solution Due to Sterility Concerns

KRS Global Biotechnology is recalling 1,815 syringes of a sterile ophthalmic topical solution because the company cannot assure 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. According to the rubric, an FDA Class II recall involving a sterile medical product where sterility assurance is compromised is rated as Severe (4) due to the significant risk of infection, even without reported injuries.

Plain-English summary

KRS Global Biotechnology, Inc. is recalling 1,815 syringes of Cyclopentolate HCl 1% / Phenylephrine HCl 2.5% / Tropicamide 1% / Ketorolac Tromethamine 0.5% Sterile Ophthalmic Topical Solution. The product is a prescription-only, sterile ophthalmic topical solution packaged in 3 mL syringes with a 0.5 mL fill. The recall is being conducted because the company lacks assurance of the product's sterility.

The affected product is identified by NDC 3321677510. The recall covers all lots remaining within their expiration dates. The product was distributed nationwide.

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% (5 mg/0.5 mL) / Phenylephrine HCl 2.5% (12.5 mg/0.5 mL) / Tropicamide 1% (5 mg/0.5 mL) / Ketorolac Tromethamine 0.5% (2.5 mg/0.5 mL), Sterile Ophthalmic Topical Solution, 0.5 mL Fill in 3 mL Syringe, Rx Only, KRS Global Biotechnology 791 Park of Commerce…
Manufacturer
KRS Global Biotechnology, Inc
Category
Drug — Ophthalmic
Hazard
Affected units
1,815

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.

See all 80 products in this recall →

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