DrugMar 8, 2023
Daptomycin for Injection 350 mg/vial recall — FDA D-0381-2023
CGMP Deviations: recalling drug products following an FDA inspection.
Class IIFDA: TerminatedAccord Healthcare, Inc.
March 2023 recalls — page 29
These records include useful source details for the selected month.
DrugMar 8, 2023
Daptomycin for Injection 500 mg per vial, Single-dose vial recall — FDA D-0382-2023
CGMP Deviations: recalling drug products following an FDA inspection.
Class IIFDA: TerminatedAccord Healthcare, Inc.
DrugMar 8, 2023
Accord Healthcare Phenylephrine Hydrochloride Injection, USP 100 mg/10 mL (10 mg/mL) recall — FDA D-0403-2023
CGMP Deviations: recalling drug products following an FDA inspection.
Class IIFDA: TerminatedAccord Healthcare, Inc.
DrugMar 8, 2023
The Harvard Drug Group Carbidopa and Levodopa Tablets, USP 25 mg/100 mg, 10x10 Unit Dose recall — FDA D-0432-2023
Packaging defect: observed packaging defect, blister packaging inadequately sealed.
Class IIFDA: TerminatedThe Harvard Drug Group
DrugMar 8, 2023
Simvastatin Tablets USP 20 mg recall — FDA D-0410-2023
CGMP Deviations: recalling drug products following an FDA inspection.
Class IIFDA: TerminatedAccord Healthcare, Inc.
DrugMar 8, 2023
Nephron Sterile Compounding Center Norepinephrine Bitartrate in 0.9% Sodium Chloride recall — FDA D-0357-2023
Lack of Assurance of Sterility
Class IIFDA: TerminatedNephron Sterile Compounding Center LLC
DrugMar 8, 2023
rOPINIRole Tablets USP 1 mg*, 100-count bottle recall — FDA D-0427-2023
CGMP Deviations: recalling drug products following an FDA inspection.
Class IIFDA: TerminatedAccord Healthcare, Inc.
DrugMar 8, 2023
Accord Healthcare Succinylcholine Chloride Injection, USP, 200 mg/10 mL (20 mg/mL), 10 mL recall — FDA D-0413-2023
CGMP Deviations: recalling drug products following an FDA inspection.
Class IIFDA: TerminatedAccord Healthcare, Inc.
DrugMar 8, 2023
Nephron Sterile Compounding Center Phenylephrine HCl Injection, USP, 0.4 mg/10 mL recall — FDA D-0360-2023
Lack of Assurance of Sterility
Class IIFDA: TerminatedNephron Sterile Compounding Center LLC
DrugMar 8, 2023
DuPont Nutrition USA Avicel PH- 101 NF, Microcrystalline Cellulose, NF, Ph recall — FDA D-0349-2023
Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity.
Class IIIFDA: TerminatedDuPont Nutrition USA, Inc.
DrugMar 8, 2023
Nephron Sterile Compounding Center Diltiazem HCl in 0.7% Sodium Chloride Injection, 125 recall — FDA D-0355-2023
Lack of Assurance of Sterility
Class IIFDA: TerminatedNephron Sterile Compounding Center LLC
DrugMar 8, 2023
Pirfenidone Tablets 801 mg recall — FDA D-0420-2023
CGMP Deviations: recalling drug products following an FDA inspection.
Class IIFDA: TerminatedAccord Healthcare, Inc.
DrugMar 8, 2023
BusPIRone Hydrochloride Tablets USP 7.5 mg, 100-count bottle recall — FDA D-0375-2023
CGMP Deviations: recalling drug products following an FDA inspection.
Class IIFDA: TerminatedAccord Healthcare, Inc.
DrugMar 8, 2023
rOPINIRole Tablets USP 3 mg*, 100-count bottle recall — FDA D-0429-2023
CGMP Deviations: recalling drug products following an FDA inspection.
Class IIFDA: TerminatedAccord Healthcare, Inc.
DrugMar 8, 2023
rOPINIRole Tablets USP 5 mg* 100-count bottle recall — FDA D-0431-2023
CGMP Deviations: recalling drug products following an FDA inspection.
Class IIFDA: TerminatedAccord Healthcare, Inc.
DrugMar 8, 2023
BusPIRone Hydrochloride Tablets USP, 10 mg 500-count bottle recall — FDA D-0378-2023
CGMP Deviations: recalling drug products following an FDA inspection.
Class IIFDA: TerminatedAccord Healthcare, Inc.
DrugMar 8, 2023
rOPINIRole Tablets USP 2 mg*, 100-count bottle recall — FDA D-0428-2023
CGMP Deviations: recalling drug products following an FDA inspection.
Class IIFDA: TerminatedAccord Healthcare, Inc.
DrugMar 8, 2023
Accord Healthcare Phenylephrine Hydrochloride Injection, USP 10 mg/mL recall — FDA D-0401-2023
CGMP Deviations: recalling drug products following an FDA inspection.
Class IIFDA: TerminatedAccord Healthcare, Inc.
DrugMar 8, 2023
DuPont Nutrition USA Avicel PH- 102 NF, Microcrystalline Cellulose, NF, Ph recall — FDA D-0350-2023
Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity.
Class IIIFDA: TerminatedDuPont Nutrition USA, Inc.
DrugMar 8, 2023
Rosuvastatin Tablets, USP 20 mg* recall — FDA D-0406-2023
CGMP Deviations: recalling drug products following an FDA inspection.
Class IIFDA: TerminatedAccord Healthcare, Inc.
DrugMar 8, 2023
Doxazosin Tablets USP 1 mg recall — FDA D-0386-2023
CGMP Deviations: recalling drug products following an FDA inspection.
Class IIFDA: TerminatedAccord Healthcare, Inc.
DrugMar 8, 2023
Doxazosin Tablets USP, 8 mg recall — FDA D-0389-2023
CGMP Deviations: recalling drug products following an FDA inspection.
Class IIFDA: TerminatedAccord Healthcare, Inc.
DrugMar 8, 2023
Pravastatin Sodium Tablets USP, 40 mg recall — FDA D-0423-2023
CGMP Deviations: recalling drug products following an FDA inspection.
Class IIFDA: TerminatedAccord Healthcare, Inc.
DrugMar 8, 2023
Nephron Sterile Compounding Center Phenylephrine HCl in 0.9% Sodium Chloride Injection, USP recall — FDA D-0362-2023
Lack of Assurance of Sterility
Class IIFDA: TerminatedNephron Sterile Compounding Center LLC
How to use this monthly recall archive
Use this page to compare the recalls reported during the month, then open an individual record for the exact reason, classification, company, remedy or distribution information available from the official source. Monthly counts are descriptive, not a safety rating.