The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0076-2020·Announced 2019-10-09

KRS Global Biotechnology Recalls Moxifloxacin Ophthalmic Injection Due to Sterility Concerns

KRS Global Biotechnology is recalling Moxifloxacin 0.1% ophthalmic injection syringes due to a lack of assurance of sterility. The recall covers 9,920 syringes distributed nationwide.

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 assurance of sterility in an ophthalmic injection, which poses a significant risk of infection or serious injury.

Plain-English summary

KRS Global Biotechnology, Inc. is recalling Moxifloxacin 0.1% in BSS, Ophthalmic Injection, 0.3 mg/0.3 mL, 0.3 mL Fill in a 1 mL Single Dose Syringe. The recall was initiated due to a lack of assurance of sterility. The product is prescription-only and is identified by NDC 3321678320.

The recall involves 9,920 syringes. The distribution pattern is nationwide, and the recall includes all lots remaining within their expiry dates. The manufacturer is located in Boca Raton, Florida.

Consumers and healthcare providers should stop using the affected product and contact their healthcare provider or the manufacturer for further instructions. This recall is classified as Class II by the FDA.

The recalled product

Product
Moxifloxacin 0.1% in BSS, Ophthalmic Injection, 0.3 mg/0.3 mL, 0.3 mL Fill in a 1 mL Single Dose Syringe, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678320
Manufacturer
KRS Global Biotechnology, Inc
Category
Drug — Ophthalmic Injection
Hazard
Affected units
9,920

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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