FDA (Drugs) recall action 80638
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.
CGMP deviations: Product was released while a hood certification discrepancy was being investigated.
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.
PharMEDium Services is recalling 450 syringes of Ephedrine Sulfate because the product was released while a hood certification discrepancy was under investigation.
PharMEDium Services, LLC is recalling 575 syringes of 10 mg/mL Rocuronium Bromide because the product was released while a hood certification discrepancy was under investigation.
PharMEDium Services is recalling specific lots of Fentanyl Citrate IV bags because they were released while a hood certification discrepancy was under investigation.