FDA (Drugs) recall action 93265
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: Silicone
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.
Exela Pharma Sciences recalls 8.4% sodium bicarbonate injection nationwide due to silicone particulate matter in vials. The FDA classified this Class I recall as affecting 355,220 vials.
Exela Pharma Sciences is recalling 38,200 vials of ELCYS (cysteine hydrochloride injection) nationwide due to the presence of silicone particulate matter.
Exela Pharma Sciences is recalling Midazolam Injectable due to silicone particulate matter contamination. Patients and healthcare providers with the affected lot should discontinue use and consult their healthcare provider.