FDA (Drugs) recall action 78828
The FDA (Drugs) publishes a recall like this one as 42 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 42 pages.
Lack of sterility assurance.
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 all lots of Morphine Sulfate in 0.9% Sodium Chloride nationwide due to a lack of sterility assurance.
Pharmedium Services, LLC is recalling Lidocaine HCl in 0.9% Sodium Chloride nationwide due to a lack of sterility assurance.
Pharmedium Services, LLC is recalling Hydromorphone HCl in 5% Dextrose in all strengths and packaging due to a lack of sterility assurance.
Pharmedium Services, LLC is recalling all lots of Atropine Sulfate Injection nationwide due to a lack of sterility assurance.
Pharmedium Services, LLC is recalling all lots of Ketamine HCl Injection because of a lack of sterility assurance. The recall covers all strengths, doses, and packaging distributed nationwide.
Pharmedium Services, LLC is recalling all lots of Neostigmine Methylsulfate Injection due to a lack of sterility assurance.
Pharmedium Services, LLC is recalling Methadone HCl Injection in all strengths and packaging due to a lack of sterility assurance.
Pharmedium Services, LLC is recalling Dexamethasone Sodium Phosphate in all strengths and packaging due to a lack of sterility assurance.
Pharmedium Services, LLC is recalling all lots of Phenylephrine HCl in 0.9% Sodium Chloride due to a lack of sterility assurance.
Pharmedium Services, LLC is recalling all lots of Labetalol HCl nationwide due to a lack of sterility assurance.
Pharmedium Services, LLC is recalling Labetalol HCl in 0.9% Sodium Chloride infusions nationwide due to a lack of sterility assurance.
Pharmedium Services, LLC is recalling all lots of Midazolam HCl in 5% Dextrose due to a lack of sterility assurance. The recall covers all strengths, doses, and packaging nationwide.
Pharmedium Services, LLC is recalling Ephedrine Sulfate in 0.9% Sodium Chloride nationwide due to a lack of sterility assurance.
Pharmedium Services, LLC is recalling all lots of Midazolam HCl in 0.9% Sodium Chloride due to a lack of sterility assurance.
Pharmedium Services, LLC is recalling Dexamethasone Sodium Phosphate added to 5% Dextrose nationwide due to a lack of sterility assurance.
Pharmedium Services, LLC is recalling Meperidine HCl in 0.9% Sodium Chloride injections nationwide due to a lack of sterility assurance.
Pharmedium Services, LLC is recalling all lots of Midazolam HCl Injection because of a lack of sterility assurance. The recall covers all strengths, doses, and packaging distributed nationwide.