FDA (Drugs) recall action 92752
The FDA (Drugs) publishes a recall like this one as 39 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 39 pages.
Lack of assurance of sterility: Lack of validation data for sanitization cycles
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 fentanyl injections because sterilization procedures were not properly validated, raising infection risks from potential contamination.
Central Admixture Pharmacy Services recalls 1,235 morphine syringes nationwide due to lack of validation data for sterilization cycles, potentially compromising sterility.
Central Admixture Pharmacy Services is recalling 2,077 syringes of HYDROmorphone injection (15 mg/30 mL) distributed nationwide due to lack of validation data for sanitization cycles. No adverse events have been reported.
Central Admixture Pharmacy Services Inc. is recalling morphine injections nationwide due to inadequate validation of sterilization procedures, which poses a potential sterility risk.
The FDA has recalled 3,824 bags of hydromorphone injectable solution due to lack of validated sterilization processes. The affected product may not meet required sterility assurance standards.
Central Admixture Pharmacy Services is recalling 1,669 fentanyl syringes nationwide due to lack of validation data for sanitization cycles, preventing assurance of product sterility.
FDA is recalling 81,073 PHENYLephrine syringes manufactured by Central Admixture Pharmacy Services. The manufacturer lacks validation data for its sterilization processes, so the syringes may not be sterile.
Central Admixture Pharmacy Services is recalling 720 syringes of morphine due to lack of validation data for sanitization cycles, which creates uncertainty about product sterility. The product was distributed nationwide.
Central Admixture Pharmacy Services is recalling approximately 6,770 fentanyl syringes distributed nationwide due to lack of validated sanitization data. The injectable medication may not have proper sterility assurance.
Central Admixture Pharmacy Services is recalling 2,340 fentanyl syringes distributed nationwide due to lack of sterility assurance from unvalidated sanitization procedures.
Central Admixture Pharmacy Services is recalling 2,228 HYDROmorphone injectables (0.1 mg/mL) due to lack of validation data for sanitization cycles affecting sterility assurance. Multiple lot numbers distributed nationwide are affected.
Central Admixture recalls 8,146 bags of fentanyl injection due to lack of sterilization cycle validation. This Class II recall affects patients nationwide who may receive contaminated IV medication.
Central Admixture Pharmacy Services Inc is recalling 621 syringes of midazolam injection because the manufacturer lacked validation data to confirm the sterilization process was effective.
Central Admixture Pharmacy Services is recalling 1,486 syringes of fentanyl-bupivacaine injection nationwide due to lack of validated sanitization processes that may affect product sterility.
Central Admixture Pharmacy Services is recalling 8,942 ePHEDrine syringes nationwide due to lack of validation data for sterilization procedures, creating a potential sterility risk for injectable medications.
Central Admixture Pharmacy Services is recalling 848 bags of fentanyl injection nationwide due to lack of validated sterilization processes that assure product sterility. Multiple lots distributed to healthcare facilities are affected.
Central Admixture Pharmacy Services recalled phenylephrine injectable syringes nationwide due to missing validation data for sanitization cycles. Approximately 10,494 syringes from multiple lots may not meet sterility assurance standards.
Central Admixture Pharmacy Services is recalling 1,699 morphine syringes nationwide due to lack of validated sanitization cycles, which may compromise sterility assurance.
Central Admixture Pharmacy is recalling HYDROmorphone injection syringes nationwide due to lack of validated sanitization cycles, which compromises sterility.
Central Admixture Pharmacy Services is recalling 2,389 hydromorphone injection syringes distributed nationwide due to lack of validation data for sterilization procedures, which prevents assurance of product sterility.
Vecuronium injection syringes were recalled nationwide due to lack of validation data for sanitization cycles, which raises sterility assurance concerns.
Central Admixture Pharmacy Services is recalling rocuronium syringes due to lack of validation data for sanitization cycles, which cannot assure sterility. The recall affects 10,065 syringes distributed nationwide.
Central Admixture Pharmacy Services is recalling 896 bags of fentanyl-bupivacaine injectable solution nationwide due to lack of sterility assurance. The FDA Class II recall affects compounded pain medication lacking adequate sterilization validation.
Central Admixture Pharmacy Services recalls 295 bags of injectable fentanyl-bupivacaine solution nationwide because the sterilization process lacked proper validation documentation.
Central Admixture Pharmacy Services is recalling 1,114 bags of fentanyl and bupivacaine injectable due to lack of validation data for sterilization. The product was distributed nationwide.