Moxifloxacin Ophthalmic Injection Syringes Recalled for Sterility Risk
Edge Pharma is recalling Moxifloxacin sterile ophthalmic injection syringes nationwide due to lack of assurance of sterility. The 860 affected syringes were distributed across two lots.
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 FDA classified this as a Class II recall. The hazard—lack of sterility assurance in a preservative-free intraocular injectable—presents significant risk of serious harm (infection, vision loss) to patients undergoing eye injection procedures, even though no illnesses or injuries are reported in the source text.
Plain-English summary
Edge Pharma, LLC is recalling Moxifloxacin, Sterile Ophthalmic Solution for Injection, Preservative Free, 0.8mg/0.8 mL (1mg/mL), 0.8 mL per syringe, Single Use Syringe, For Intraocular Injection (NDC 05446-1050-01) due to lack of assurance of sterility.
The recall affects 860 syringes distributed nationwide. The affected product was manufactured in two lots: 08-2021-26@2 dated 12/09/2021 and 09-2021-23@1 dated 01/05/2022.
Patients and healthcare providers who received this product should discontinue use. Those with questions about whether they received affected product should contact Edge Pharma, LLC at 856 Hercules Dr., Colchester, VT 05446, or refer to the FDA's official recall notice.
The recalled product
- Product
- Moxifloxacin, Sterile Ophthalmic Solution for Injection, Preservative Free, 0.8mg/0.8 mL (1mg/mL), 0.8 mL per syringe, Single Use Syringe, For Intraocular Injection, Edge Pharma, LL, 856 Hercules Dr., Colchester, VT 05446, NDC 05446-1050-01
- Manufacturer
- Edge Pharma, LLC
- Category
- Drug — Ophthalmic Injection
- Affected units
- 860
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)
- 08-2021-26@2 12/09/2021 & 09-2021-23@1 01/05/2022
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 56 recalled by Edge Pharma, LLC 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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