April 10, 2024DrugsFDA
IntegraDose Compounding Services LLC recalls fentaNYL Citrate 2,500 mcg/50mL in Sterile Water, 50 mL CADD for Injection, IntegraDose Compounding Services, LLC, 719 K
Hazard: Lack of Assurance of Sterility: leaking bags
April 10, 2024DrugsFDA
B. Braun Medical Inc recalls Lactated Ringer's Injection USP, 1000mL, EXCEL CONTAINER, Rx only, B.Braun Medical Inc., Bethlehem, PA 18018, NDC 0264-7
Hazard: Lack of assurance of sterility: bags have the potential to leak..
April 10, 2024DrugsFDA
Glenmark Pharmaceuticals Inc., USA recalls Diltiazem Hydrochloride Extended-Release Capsules, USP 120 mg, Twice-a-Day Dosage, 100 Capsules per bottle, Rx Only, Man
Hazard: Failed Dissolution Specifications: Out of Specification (OOS) was reported in test of dissolution at the 12th month time point in long term stability study.
April 3, 2024DrugsFDA
Par Sterile Products LLC recalls Treprostinil Injection, 20 mg/20 mL (1 mg/mL), For Subcutaneous or Intravenous Infusion Only, 20 mL Multiple-Dose Vial,
Hazard: Presence of Particulate Matter.
April 3, 2024DrugsFDA
Teva Pharmaceuticals USA, Inc recalls Tri-Lo-Sprintec (norgestimate and ethinyl estradiol) tablets USP - triphasic regimen, packaged in carton containing 3 Bl
Hazard: Failed Dissolution Specifications
April 3, 2024DrugsFDA
Apothecus Pharmaceutical Corp. recalls VCF Vaginal Contraceptive Film (nonoxynol-9, 28%), package in a carton with 9 single films, Distributed By: Apothecus Ph
Hazard: cGMP Diviations
April 3, 2024DrugsFDA
Amneal Pharmaceuticals of New York, LLC recalls Divalproex Sodium Extended-release Tablets, USP 250 mg, Rx Only, 100 tablets, Manufactured by: Amneal Pharmaceuticals Pv
Hazard: Failed dissolution specifications
April 3, 2024DrugsFDA
SCA Pharmaceuticals, LLC recalls VANCOMYCIN 1.25 g added to 0.9% Sodium Chloride 250 mL Injection, 250 mL bag, Rx only, SCA Pharmaceuticals, 755 Rainbow
Hazard: Lack of Assurance of Sterility
April 3, 2024DrugsFDA
SCA Pharmaceuticals, LLC recalls SUCcinylcholine Chloride 100 mg/5mL Injection (Concentration = 20mg/mL), 5 mL fill 6 mL Syringe, Rx only, Repackaged by
Hazard: Lack of Assurance of Sterility
April 3, 2024DrugsFDA
SCA Pharmaceuticals, LLC recalls SUCcinylcholine Chloride 200 mg/10mL Injection (Concentration = 20mg/mL), 10 mL fill 12 mL Syringe, Rx only, Repackaged
Hazard: Lack of Assurance of Sterility
April 3, 2024DrugsFDA
SCA Pharmaceuticals, LLC recalls Sodium Citrate 4% 3 mL, Anticoagulation Solution Injection (Concentration = 40/mg/mL) 3mL fill Syringe, Repackaged by SC
Hazard: Lack of Assurance of Sterility
April 3, 2024DrugsFDA
SCA Pharmaceuticals, LLC recalls PHENYLephrine HCl 800 mcg/10 mL in 0.9% Sodium Chloride Injection, (Concentration = 80mcg/mL) 10 mL fill 12 mL Syringe,
Hazard: Lack of Assurance of Sterility
April 3, 2024DrugsFDA
SCA Pharmaceuticals, LLC recalls PHENYLephrine HCl 800 mcg/10 mL in 0.9% Sodium Chloride Injection, (Concentration = 80mcg/mL) 10 mL fill 12 mL Syringe,
Hazard: Lack of Assurance of Sterility
April 3, 2024DrugsFDA
SCA Pharmaceuticals, LLC recalls PHENYLephrine HCl 40 mg in 0.9% Sodium Chloride Injection, (Concentration = 160 mcg/mL), 250 mL Bag, Rx Only, SCA Pharma
Hazard: Lack of Assurance of Sterility
April 3, 2024DrugsFDA
SCA Pharmaceuticals, LLC recalls PHENYLephrine HCl 400 mcg/10 mL in 0.9% Sodium Chloride Injection, (Concentration = 40 mcg/mL), 10 mL fill 12 mL Syringe
Hazard: Lack of Assurance of Sterility
April 3, 2024DrugsFDA
SCA Pharmaceuticals, LLC recalls PHENYLephrine HCl 5000 mcg/50 mL in 0.9% Sodium Chloride Injection, (Concentration = 100 mcg/mL), 50 mL Syringe, Rx Only
Hazard: Lack of Assurance of Sterility
April 3, 2024DrugsFDA
SCA Pharmaceuticals, LLC recalls PHENYLephrine HCl 500 mcg/5 mL in 0.9% Sodium Chloride Injection, (Concentration = 100 mcg/mL), 5 mL fill 12 mL Syringe,
Hazard: Lack of Assurance of Sterility
April 3, 2024DrugsFDA
SCA Pharmaceuticals, LLC recalls PHENYLephrine HCl 500 mcg/5 mL in 0.9% Sodium Chloride Injection, (Concentration = 100 mcg/mL), 5 mL fill 12 mL Syringe,
Hazard: Lack of Assurance of Sterility
April 3, 2024DrugsFDA
SCA Pharmaceuticals, LLC recalls PHENYLephrine HCl 1000 mcg/10 mL in 0.9% Sodium Chloride Injection, (Concentration = 100 mcg/mL), 10 mL fill 12 mL Syrin
Hazard: Lack of Assurance of Sterility
April 3, 2024DrugsFDA
SCA Pharmaceuticals, LLC recalls neostigmine methylsulfate 5 mg/5 mL Injection, (Concentration = 1mg/mL), 5 mL fill 6 mL Syringe, Rx Only, SCA Pharma, 75
Hazard: Lack of Assurance of Sterility
April 3, 2024DrugsFDA
SCA Pharmaceuticals, LLC recalls Midazolam HCl 100 mg/100 mL in 0.9% Sodium Chloride Injection, (Concentration = 1mg/mL) 100 mL Bag, Rx Only, SCA Pharmac
Hazard: Lack of Assurance of Sterility
April 3, 2024DrugsFDA
SCA Pharmaceuticals, LLC recalls labetalol HCl 20 mg/4mL Injection, (Concentration=5 mg/mL), 4 mL fill Syringe, Rx Only, SCA Pharma, 755 Rainbow Rd., Win
Hazard: Lack of Assurance of Sterility
April 3, 2024DrugsFDA
SCA Pharmaceuticals, LLC recalls HYDROmorphone HCl 30 mg/30 mL in 0.9% Sodium Chloride Injection, (Concentration = 1mg/mL) 30 mL fill Syringe, Rx only, S
Hazard: Lack of Assurance of Sterility
April 3, 2024DrugsFDA
SCA Pharmaceuticals, LLC recalls HYDROmorphone HCl 30 mg/30mL in 0.9% Sodium Chloride Injection, (Concentration = 1 mg/ml) 30 mL fill 35 mL Plungerless S
Hazard: Lack of Assurance of Sterility
April 3, 2024DrugsFDA
SCA Pharmaceuticals, LLC recalls HYDROmorphone HCl 25 mg/25 mL in 0.9% Sodium Chloride Injection, (Concentration = 1mg/mL), 25 mL fill 30 mL Syringe, Rx
Hazard: Lack of Assurance of Sterility
April 3, 2024DrugsFDA
SCA Pharmaceuticals, LLC recalls HYDROmorphone HCl 10 mg/50 mL in 0.9% Sodium Chloride Injection (Concentration = 0.2 mg/ml) 50 mL fill Syringe, Rx only,
Hazard: Lack of Assurance of Sterility
April 3, 2024DrugsFDA
SCA Pharmaceuticals, LLC recalls HYDROmorphone HCl 6 mg/30 mL in 0.9% Sodium Chloride, (Concentration = 0.2mg/ml) 30 mL Syringe, Rx only, SCA Pharmaceuti
Hazard: Lack of Assurance of Sterility
April 3, 2024DrugsFDA
SCA Pharmaceuticals, LLC recalls HYDROmorphone HCl 6 mg/30 mL in 0.9% Sodium Chloride Injection, (Concentration = 0.2 mg/ml) 30 mL fill 35 mL Plungerless
Hazard: Lack of Assurance of Sterility
April 3, 2024DrugsFDA
SCA Pharmaceuticals, LLC recalls HYDROmorphone HCl 20 mg/100mL in 0.9% Sodium Chloride Injection, 100 mL Grey CADD Cassette (20 mg/100 mL), CII, Rx only,
Hazard: Lack of Assurance of Sterility
April 3, 2024DrugsFDA
SCA Pharmaceuticals, LLC recalls fentaNYL 2,500 mcg/50 mL in 0.9 % Sodium Chloride Injection (Concentration = 50 mcg/mL) 50 mL Single Dose Syringe, Rx On
Hazard: Lack of Assurance of Sterility