Tracker
Drug recalls
The latest FDA drug recalls. Class I is the most serious (a reasonable probability of serious harm); Class III is unlikely to cause harm.
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Class IBaxter Healthcare CorporationDextrose Injection, USP, 70 %, 2000 mL bags, Rx Only, Baxter Healthcare Corporation Deerfield, IL, 60016, Made in USA, NDC 00338-0719-06Presence of Particulate Matter: particulate matter identified as stainless steel particles in the solution.
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Class IOptimal Balance PharmacyGlutathione 200 mg/mL, 30 mL sterile multidose vial, Each vial contains: Glutathione, Ascorbic Acid, Benzyl Alcohol & sterile water for injection, For IM or IV Injection Use Only, RX only, Optimal Balance Pharmacy, 2…Microbial Contamination of Sterile Products - out of specifications results were obtained for bacterial endotoxin.
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Class IBaxter Healthcare Corporation0.9% Sodium Chloride Injection USP 500 mL, VIAFLEX Plastic Containers, with 24 units per case. Baxter Healthcare Corporation, Deerfield, IL, 60015, USA, Made in USA, NDC 0338-0049-03Presence of particulate matter: Particulates identified as fiberglass
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Class IFresenius Kabi Usa, LLCTyenne (tocilizumab-aazg) Injection, 400 mg/20 mL (20 mg/mL), 20 mL vial, Rx Only, Manufactured by Fresenius Kabi USA, LLC, Lake Zurich, Illinois, 60047, NDC 65219-594-20.Presence of particulate matter:An internal investigation at the firm found the product to contain glass particles.
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Class IB Braun Medical INCLactated Ringer's Injection USP, 1000 mL EXCEL container, Rx only, L7500, B. Braun Medical, Inc., Bethlehem, PA 18018-3524 USA, NDC 0264-7750-00Presence of Particulate matter.
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Class IAmerican Regent, Inc.Papaverine HCl Injection, USP, 60 mg/2 mL (30 mg/mL), packaged in a) 2mL Single-Dose Vial (NDC 0517-4002-01), and b) 25x2mL Single-Dose Vials (NDC 0517-4002-25), Rx Only, AMERICAN REGENT, INC., SHIRLEY, NY 11967.Presence of Particulate Matter: Product contaminated with particulate matter identified as glass and/or paraformaldehyde
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Class IFresenius Kabi Usa, LLCMorphine Sulfate Injection, USP, 2 mg /mL, 1 mL single-dose Simplist prefilled syringes, For Intramuscular or Intravenous use, Rx only, Fresenius Kabi, Lake Zurich, IL. Unit of Use NDC Number 76045-004-01; Unit of Sal…Labeling: Label Mixup: MicroVault labeled as Morphine 2 mg/1 mL, contains a Prefilled Syringe of Dilaudid 0.5 mg/0.5 mL.
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Class IBuy-herbalKian Pee Wan Capsules, 30-count bottlesMarketed Without an Approved NDA/ANDA: Product contains undeclared drug ingredients dexamethasone and cyproheptadine.
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Class IVictory Medical Center PharmacyGlutathione (MDV), 200 mg/mL, 30 mL vial, each mL contains Glutathione 200 mg, Ascorbic Acid 20 mg, Benzyl Alcohol 1.5%, Na Hydroxide (Ph Adjust) in sterile water for injection, VMC.Microbial Contamination of Sterile Products - out of specifications results were obtained for bacterial endotoxin.
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Class ILiebel-flarsheim Company LLCOptiray Imaging Bulk Package-350, Ioversol Injection 74%, 350 mg/mL Organically Bound Iodine, 500 mL Multiple-Dose Vial, Rx only, Sterile Solution, Manufactured by: Liebel-Flarsheim Company LLC, Raleigh, NC 27616, Mad…Presence of Particulate Matter: comprising polyethylene and other plastic materials, stainless steel and glass.
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Class IBaxter Healthcare CorporationCefazolin in Dextrose, Injection, USP, 2g / 100mL (20mg / mL) Single-Dose Infusion Bag in 100mL GALAXY Plastic Container, Frozen Premix, Sterile, Rx only, Manufactured by Baxter Healthcare Corporation, Deerfield, IL 6…Presence of Particulate Matter
Source: openFDA drug enforcement reports. Recalls are reported weekly.