FDA (Drugs) recall action 92707
The FDA (Drugs) publishes a recall like this one as 95 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 95 pages.
Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
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.
Central Admixture Pharmacy Services is recalling 3,821 bags of oxytocin IV bags nationwide due to lack of sterility assurance and missing validation data for decontamination cycles.
Central Admixture Pharmacy Services is recalling phenylephrine IV bags nationwide due to insufficient sterility assurance and lack of validation data for decontamination cycles used in manufacturing.
Central Admixture Pharmacy Services recalled 96 neonatal TPN IV bags (Lot 36-256336) due to lack of sterility assurance and missing validation data for decontamination cycles. The product was distributed nationwide.
Central Admixture Pharmacy Services is recalling 12 IV bags of Transplant Solution nationwide (Lot 36-252141) because the sterilization decontamination cycles lack proper validation, creating a sterility assurance deficiency.
Central Admixture Pharmacy Services is recalling 356 neonatal TPN starter bags due to lack of validation data for decontamination cycles. The sterility of the affected lots cannot be assured.
Central Admixture Pharmacy Services is recalling 224 neonatal TPN starter bags (250mL IV bags) distributed nationwide due to lack of sterility assurance and insufficient validation data for decontamination cycles.
Central Admixture Pharmacy Services recalls 33,073 bags of oxytocin 30 units with Lactated Ringer's 500 mL IV solution nationwide due to lack of validated sterilization. No illnesses reported.
Central Admixture Pharmacy Services is recalling 84 bags of neonatal TPN starter bags due to lack of sterility assurance and missing validation data for decontamination cycles.
Central Admixture Pharmacy Services is recalling 3,648 bags of vancomycin IV bags due to lack of assurance of sterility caused by insufficient validation data for decontamination cycles.
Central Admixture Pharmacy Services is recalling cardioplegia solution IV bags nationwide due to lack of validated sterilization processes. The recall affects 184 bags from two lots.
Central Admixture Pharmacy Services recalls Cardioplegia Solution (Lot 36-253947) due to lack of sterility assurance and insufficient decontamination validation. Healthcare facilities should discontinue use and contact the manufacturer.
Central Admixture Pharmacy Services is recalling 448 bags of heparin 7500 units in 0.9% sodium chloride IV solution due to lack of assurance of sterility. Validation data for decontamination cycles was not established.
Central Admixture Pharmacy Services recalls 420 bags of neonatal TPN containing amino acids and dextrose due to lack of assurance of sterility. Validation data for decontamination cycles was not available.
Central Admixture Pharmacy Services is recalling a cardioplegia solution nationwide due to lack of sterility assurance and insufficient validation data for sterilization decontamination cycles.
The FDA has recalled Central Admixture Pharmacy Services' Cardioplegia Solution 40 mEq K due to insufficient validation data for sterilization processes. The 80-bag lot may not meet sterility standards required for cardiac use.
Central Admixture Pharmacy Services is recalling 333 units of epinephrine 2 mg in dextrose 5% IV bags because validation data for sterilization procedures is lacking, raising concerns about product sterility assurance.
Central Admixture Pharmacy Services is recalling a cardioplegia solution used during heart surgery due to insufficient validation data for sterilization cycles. The 104-bag recall covers products distributed nationwide.
Central Admixture Pharmacy Services is recalling a cardioplegia solution used in cardiac surgery due to lack of sterility assurance and missing decontamination validation data. The affected lot was distributed nationwide.
Central Admixture Pharmacy Services is recalling 4,824 bags of vancomycin IV medication nationwide due to inadequate validation of sterilization processes. The manufacturer cannot confirm proper sterility.
Central Admixture Pharmacy Services is recalling 2,260 dilTIAZem IV bags nationwide because validation data for the decontamination process is lacking. Affected lots expire between July and August 2023.
Central Admixture Pharmacy Services is recalling 3,699 bags of dilTIAZem IV medication due to lack of assurance of sterility and missing validation data for decontamination cycles. The affected medication was distributed nationwide.
Central Admixture Pharmacy Services is recalling 296 bags of neonatal TPN starter solution due to lacking validation data for decontamination cycles, raising concerns about sterility assurance.
Central Admixture Pharmacy Services is recalling 56 bags of Cardioplegia Solution due to lack of sterility assurance and missing validation data for decontamination cycles. Product was distributed nationwide.
Central Admixture Pharmacy Services is recalling oxytocin IV bags nationwide due to insufficient validation of sterilization decontamination processes. The recall affects 6,037 bags distributed across multiple lots.
Central Admixture Pharmacy Services is recalling 9,121 epinephrine IV bags distributed nationwide due to lack of sterility assurance and insufficient validation data for decontamination cycles.