DrugAug 9, 2023
The Ritedose Cromolyn Sodium Oral Solution (Concentrate) 100 mg/5 mL 96 Plastic Ampules per recall — FDA D-0946-2023
CGMP deviation: product released prior to supplier approval.
Class IIFDA: CompletedThe Ritedose Corporation
Monthly breakdown
2023 recalls by month
Select a month to review the recall records reported during that period.
December 2023295 records · 4 categoriesNovember 2023387 records · 4 categoriesOctober 2023214 records · 4 categoriesSeptember 2023253 records · 4 categoriesAugust 2023478 records · 4 categoriesJuly 2023263 records · 4 categoriesJune 2023339 records · 4 categoriesMay 2023410 records · 4 categoriesApril 2023189 records · 4 categoriesMarch 2023788 records · 4 categoriesFebruary 2023253 records · 4 categoriesJanuary 2023205 records · 4 categories
2023 recalls — page 66
Records are ordered by the best available source date.
DrugAug 9, 2023
Central Admixture Pharmacy Services morphine in 0.9% sodium chloride, 1 mg/1 mL, (1 mg/mL) recall — FDA D-1064-2023
Lack of assurance of sterility: Lack of validation data for sanitization cycles
Class IIFDA: TerminatedCentral Admixture Pharmacy Services Inc.
DrugAug 9, 2023
Central Admixture Pharmacy Services phenylephrine 50 mg added to 0.9% sodium chloride 250mL recall — FDA D-0964-2023
Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
Class IIFDA: TerminatedCentral Admixture Pharmacy Services, Inc.
DrugAug 9, 2023
Central Admixture Pharmacy Services oxyTOCIN 30 units added to dextrose 5%/lactated ringers recall — FDA D-1003-2023
Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
Class IIFDA: TerminatedCentral Admixture Pharmacy Services, Inc.
DrugAug 9, 2023
Central Admixture Pharmacy Services phenylephrine, 25mg added to 0.9% sodium chloride 250 recall — FDA D-0962-2023
Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
Class IIFDA: TerminatedCentral Admixture Pharmacy Services, Inc.
DrugAug 9, 2023
Central Admixture Pharmacy Services CARDIOPLEGIA SOLUTION, 48 mEq K, Induction 4:1 in recall — FDA D-1024-2023
Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
Class IIFDA: TerminatedCentral Admixture Pharmacy Services, Inc.
DrugAug 9, 2023
Central Admixture Pharmacy Services PHENYLephrine in 0.9 sodium chloride, 800 mcg /10 mL recall — FDA D-1077-2023
Lack of assurance of sterility: Lack of validation data for sanitization cycles
Class IIFDA: TerminatedCentral Admixture Pharmacy Services Inc.
DrugAug 9, 2023
Central Admixture Pharmacy Services HYDROmorphone added to 0.9% sodium chloride, 10 mg/50 recall — FDA D-1052-2023
Lack of assurance of sterility: Lack of validation data for sanitization cycles
Class IIFDA: TerminatedCentral Admixture Pharmacy Services Inc.
DrugAug 9, 2023
Central Admixture Pharmacy Services CARDIOPLEGIA SOLUTION, 15 mEq K, Reperfusate 4:1, low recall — FDA D-1022-2023
Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
Class IIFDA: TerminatedCentral Admixture Pharmacy Services, Inc.
DrugAug 9, 2023
Central Admixture Pharmacy Services Neonatal TPN Starter Bag, Amino Acids (trophamine) recall — FDA D-1001-2023
Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
Class IIFDA: TerminatedCentral Admixture Pharmacy Services, Inc.
DrugAug 9, 2023
Central Admixture Pharmacy Services oxyTOCIN 30 units added to Lactated Ringer's 500 mL, IV recall — FDA D-1012-2023
Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
Class IIFDA: TerminatedCentral Admixture Pharmacy Services, Inc.
DrugAug 9, 2023
Central Admixture Pharmacy Services fentaNYL, 5000 mcg/100 mL, (50 mcg/mL), 100 mL Bag recall — FDA D-1051-2023
Lack of assurance of sterility: Lack of validation data for sanitization cycles
Class IIFDA: TerminatedCentral Admixture Pharmacy Services Inc.
DrugAug 9, 2023
Central Admixture Pharmacy Services CARDIOPLEGIA SOLUTION, 108 mEq K, Induction 8:1, High recall — FDA D-1032-2023
Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
Class IIFDA: TerminatedCentral Admixture Pharmacy Services, Inc.
DrugAug 9, 2023
Central Admixture Pharmacy Services fentaNYL, 1250 mcg/25 mL, (50 mcg/mL), 30 mL Syringe recall — FDA D-1043-2023
Lack of assurance of sterility: Lack of validation data for sanitization cycles
Class IIFDA: TerminatedCentral Admixture Pharmacy Services Inc.
DrugAug 9, 2023
Central Admixture Pharmacy Services midazolam in dextrose 5%, 50 mg /50 mL, (1 mg/mL), 50 mL recall — FDA D-1075-2023
Lack of assurance of sterility: Lack of validation data for sanitization cycles
Class IIFDA: TerminatedCentral Admixture Pharmacy Services Inc.
DrugAug 9, 2023
Central Admixture Pharmacy Services fentaNYL in 0.9% sodium chloride, 5000 mcg/250 mL recall — FDA D-1063-2023
Lack of assurance of sterility: Lack of validation data for sanitization cycles
Class IIFDA: TerminatedCentral Admixture Pharmacy Services Inc.
DrugAug 9, 2023
Central Admixture Pharmacy Services morphine in 0.9% sodium chloride, 125 mg/25 mL recall — FDA D-1068-2023
Lack of assurance of sterility: Lack of validation data for sanitization cycles
Class IIFDA: TerminatedCentral Admixture Pharmacy Services Inc.
DrugAug 9, 2023
Tydemy recall — FDA D-1081-2023
Failed Stability Specification and Failed Impurities/Degradation Specifications: out of specification for inactive content ascorbic acid and MTHFRC-7impurity test
Class IFDA: TerminatedLupin Pharmaceuticals Inc.
DrugAug 9, 2023
Central Admixture Pharmacy Services HYDROmorphone in 0.9% sodium chloride, 15 mg/30 mL recall — FDA D-1058-2023
Lack of assurance of sterility: Lack of validation data for sanitization cycles
Class IIFDA: TerminatedCentral Admixture Pharmacy Services Inc.
DrugAug 9, 2023
Central Admixture Pharmacy Services vancomycin 1.5 g/250mL added to 5% dextrose, 6 mg/mL, IV recall — FDA D-0968-2023
Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
Class IIFDA: TerminatedCentral Admixture Pharmacy Services, Inc.
DrugAug 9, 2023
Central Admixture Pharmacy Services Neonatal TPN Starter Bag, Amino Acids (trophamine) recall — FDA D-1002-2023
Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
Class IIFDA: TerminatedCentral Admixture Pharmacy Services, Inc.
VehicleAug 4, 2023
Subaru of instrument cluster/panel recall — NHTSA campaign 23V551000
Subaru of America, Inc. (Subaru) is recalling certain 2024 Crosstrek and Impreza vehicles. Due to insufficient clearance, the instrument panel harness may contact the steering beam bracket,…
instrument cluster/panelSubaru of America, Inc.
VehicleAug 4, 2023
Tucson labels recall — NHTSA campaign 23V556000
Hyundai Motor America (Hyundai) is recalling certain 2024 Tucson vehicles. The tire and loading information label may incorrectly indicate information about a spare tire. As such, these…
labelsHyundai Motor America
VehicleAug 3, 2023
Bronco park pawl recall — NHTSA campaign 23V546000
Ford Motor Company (Ford) is recalling certain 2023 Bronco vehicles. The transmission park system may have been damaged during assembly, which can prevent the parking pawl from fully…
park pawlFord Motor Company
About the 2023 recall archive
This archive groups records by their reported or recall date. It does not imply that every recall was initiated, announced and resolved during the same calendar year. Open the individual record for the exact dates and source details supplied by FDA or NHTSA.