FDA (Drugs) recall action 94071
The FDA (Drugs) publishes a recall like this one as 3 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 3 pages.
Presence of Particulate Matter: glass vials from the manufacturer showed signs of glass delamination.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Denver Solutions is recalling 10,020 vials of Moxifloxacin 5mg/ml nationwide due to glass delamination in the vial packaging. Affected lots: 2331123 (exp. 2/28/24) and 2331298 (exp. 3/24/24).
Denver Solutions is recalling Lidocaine-Phenylephrine injectable vials nationwide due to glass delamination in the vials. The defect could potentially introduce glass fragments into the medication.
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.