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.
What this means for you
Illness, injury, or structural failure has been reported. 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
- 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.
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