The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0060-2020·Announced 2019-10-09

FDA Recalls Hyaluronidase Ophthalmic Injection Due to Sterility Concerns

KRS Global Biotechnology is recalling 928 vials of Hyaluronidase Ophthalmic Injection because the product lacks assurance of 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 source text explicitly identifies the recall as FDA Class II. According to the severity rubric, an FDA Class II recall is classified as Severe (Score 4), particularly given the risk of infection associated with a lack of sterility assurance in an ophthalmic injection.

Plain-English summary

The U.S. Food and Drug Administration (FDA) has issued a Class II recall for Hyaluronidase (PF) Ophthalmic Injection 450 Units/3 mL (150 Units/mL) manufactured by KRS Global Biotechnology, Inc. The recall involves 928 vials of the product, which is distributed nationwide. The specific reason for the recall is a lack of assurance of sterility.

The recalled product is identified by NDC 3321678359 and is packaged as a 3 mL fill in a 5 mL single-dose vial. It is a prescription-only medication. The recall covers all lots remaining within their expiry dates. No specific lot numbers or expiration dates are provided in the source text.

Consumers and healthcare providers should stop using the recalled product and contact their healthcare provider or the manufacturer for further instructions. The FDA classifies this as a Class II recall, indicating that use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

The recalled product

Product
Hyaluronidase (PF) Ophthalmic Injection 450 Units/3 mL (150 Units/mL) 3 mL Fill in a 5 mL Single Dose Vial, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678359
Manufacturer
KRS Global Biotechnology, Inc
Category
Drug — Ophthalmic Injection
Hazard
Affected units
928

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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