The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0052-2020·Announced 2019-10-09

KRS Global Fluorescein Vials Recalled for Sterility Assurance Issues

KRS Global Biotechnology is recalling Fluorescein vials 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 recall is classified as FDA Class II and involves a lack of sterility assurance for an intravenous product, which poses a significant risk of serious injury or infection.

Plain-English summary

KRS Global Biotechnology, Inc. is recalling 1,980 vials of Fluorescein (PF) Lyophilized-For IV Use, Single Dose Vial, 500 mg/vial. The product is identified by NDC 3321676632. The recall covers all lots remaining within their expiration dates.

The recall was initiated due to a lack of assurance of sterility. The agency has classified this recall as Class II. The product was distributed nationwide.

Healthcare providers and patients should stop using the affected Fluorescein vials. Consumers should contact their healthcare provider for further instructions regarding the recall.

The recalled product

Product
Fluorescein (PF) Lyophilized-For IV Use, Single Dose Vial, 500 mg/vial, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321676632
Manufacturer
KRS Global Biotechnology, Inc
Category
Drug — Intravenous Medication
Hazard
Affected units
1,980

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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