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 Adenosine Injection because of a lack of sterility assurance. The recall covers products distributed nationwide.
Pharmedium Services, LLC is recalling Dexamethasone Sodium Phosphate added to 0.9% Sodium Chloride in all strengths, doses, and packaging due to a lack of sterility assurance.
Pharmedium Services, LLC is recalling all strengths and packaging of Glycopyrrolate due to a lack of sterility assurance. The recall covers all lots remaining within their expiry dates nationwide.
Pharmedium Services, LLC is recalling all lots of Ephedrine Sulfate Injection due to a lack of sterility assurance.
Pharmedium Services, LLC is recalling Fentanyl Citrate Injection in all strengths and packaging due to a lack of sterility assurance.
Pharmedium Services, LLC is recalling all lots of Nicardipine HCl because the product lacks sterility assurance. The recall covers all strengths, doses, and packaging distributed nationwide.
Pharmedium Services, LLC is recalling Ropivacaine HCl Injection in all strengths and packaging due to a lack of sterility assurance.
Pharmedium Services, LLC is recalling all lots of Hydromorphone HCl Injection due to a lack of sterility assurance. The recall covers all strengths, doses, and packaging nationwide.
Pharmedium Services, LLC is recalling Fentanyl Citrate and Bupivacaine HCl injections due to a lack of sterility assurance. The recall covers all strengths, doses, and packaging nationwide.
Pharmedium Services, LLC is recalling all lots of Lidocaine HCl due to a lack of sterility assurance. The recall covers products distributed nationwide in the U.S.
Pharmedium Services, LLC is recalling Esmolol HCl in all strengths and packaging due to a lack of sterility assurance.
Pharmedium Services, LLC is recalling all strengths and doses of Succinylcholine Chloride due to a lack of sterility assurance.
Pharmedium Services, LLC is recalling Vecuronium Bromide in Sterile Water for Injection due to a lack of sterility assurance. The recall covers all lots remaining within expiry nationwide.
Pharmedium Services, LLC is recalling all lots of Potassium Chloride in 5% Dextrose due to a lack of sterility assurance. The recall covers all strengths, doses, and packaging nationwide.
Pharmedium Services, LLC is recalling all lots of Ropivacaine HCl in 0.9% Sodium Chloride due to a lack of sterility assurance. The recall covers all strengths, doses, and packaging nationwide.
Pharmedium Services, LLC is recalling all lots of Methadone HCl in 0.9% Sodium Chloride due to a lack of sterility assurance.
Pharmedium Services, LLC is recalling all lots of Hydromorphone HCl in Sodium Chloride 0.9% due to a lack of sterility assurance.
Pharmedium Services, LLC is recalling Morphine Sulfate in 5% Dextrose in all strengths and packaging due to a lack of sterility assurance.
Pharmedium Services, LLC is recalling all lots of Ketamine HCl in 0.9% Sodium Chloride due to a lack of sterility assurance. The recall covers all strengths, doses, and packaging nationwide.
Pharmedium Services, LLC is recalling Bupivacaine HCl in 0.9% Sodium Chloride due to a lack of sterility assurance. The recall covers 297 bags distributed nationwide.
Pharmedium Services, LLC is recalling Fentanyl Citrate and Ropivacaine HCl injections because of a lack of sterility assurance. The recall covers all lots remaining within their expiry dates nationwide.
Pharmedium Services, LLC is recalling all lots of Nicardipine HCl in 0.9% Sodium Chloride due to a lack of sterility assurance.
Pharmedium Services, LLC is recalling all lots of Fentanyl Citrate in 0.9% Sodium Chloride due to a lack of sterility assurance.
Pharmedium Services, LLC is recalling all lots of Potassium Chloride in 0.9% Sodium Chloride due to a lack of sterility assurance.
Pharmedium Services, LLC is recalling all Rocuronium Bromide products due to a lack of sterility assurance. The recall covers all strengths, doses, and packaging nationwide.