FDA (Drugs) recall action 79063
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.
Lack of assurance of sterility: Three lots were released where there was a failure to follow proper testing and investigation procedures. Product may be out of specification (OOS) for endotoxin.
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, LLC is recalling 21 cassettes of 0.2% Ropivacaine HCI due to a failure to follow proper testing procedures, raising concerns about sterility and endotoxin levels.
PharMEDium Services, LLC is recalling 500 syringes of Phenylephrine HCl Injection due to a lack of assurance of sterility and potential endotoxin issues.
PharMEDium Services, LLC is recalling 24 bags of Oxytocin Injection due to a lack of assurance of sterility and potential endotoxin issues.