Moxifloxacin Ophthalmic Injection Solution Recalled for Glass Particle Contamination
Denver Solutions is recalling Moxifloxacin PF eye injection vials nationwide due to glass delamination in the vials. The affected product is used for eye surgery injections.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall of an ophthalmic injection with glass delamination. Particulate glass poses serious risk when injected directly into the eye, meeting the 'risk-of-harm product' criterion for High severity despite no injuries reported in source.
Plain-English summary
Denver Solutions, LLC is recalling Moxifloxacin PF 1mg/ml in Sterile Balanced Salt Solution, a sterile antibiotic injection used during eye surgery. The recall affects 40,090 single-dose vials (NDC 71449-096-42) distributed nationwide.
The recall is due to glass delamination in the vials. Delamination can introduce particulate glass into the medication, which poses a risk when the product is injected directly into the eye during surgical procedures.
The affected product has the following lot numbers and expiration dates: Lot 2331147 (expires 6-Mar-24), Lot 2331180 (expires 21-Mar-24), Lot 2331256 (expires 2-Apr-24), Lot 2331279 (expires 3-Apr-24), Lot 2331283 (expires 7-Apr-24), Lot 2331345 (expires 20-Apr-24), Lot 2331422 (expires 27-Apr-24), and Lot 2331563 (expires 29-May-24).
Consumers, healthcare providers, and pharmacies should stop using affected vials immediately and contact their supplier for replacement stock. If any vials from the recalled lots have been used, patients should consult their healthcare provider about their treatment.
The recalled product
- Product
- Moxifloxacin PF, 1mg/ml, in Sterile Balanced Salt Solution (BSS) Sterile injection, Intracameral Use Only, Single- Dose Vial, Leiters 13796 Compark Blvd, Englewood, CO 80112, NDC 71449-096-42
- Manufacturer
- Denver Solutions, LLC DBA Leiters Health
- Category
- Drug — Ophthalmic Injection
- Hazard
- glass-contamination
- particulate-matter
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 (16)
- Lot #:2331147
- Exp:6-Mar-24
- 2331180
- Exp: 21-Mar-24
- 2331256
- Exp: 2-Apr-24
- 2331279
- Exp: 3-Apr-24
- 2331283
- Exp: 7-Apr-24
- 2331345
- Exp: 20-Apr-24
- 2331422
- Exp: 27-Apr-24
- 2331563
- Exp: 29-May-24.
Distribution
Distributed nationwide across the United States.
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