30 loaded recalls on this report date. 7 Class I. 30 ongoing.
Food
Class I
Ongoing
Grade A White In-shell Chicken eggs packaged in the following configurations: 1. Kroger, Medium, 12 Eggs, Net Wt 21 oz (1lb 5oz) 596g, UPC 0 11110-60902 1. Distributed by...
Firm: MIDWEST POULTRY SERVC C/O H & LELECTRIC
Reason: Possible Salmonella Enteritidis
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Food
Class I
Ongoing
Dark Chocolate Coconut Almond Bites, 3.17oz, Plastic Pouches, 10 Packages per case.
Firm: Bazzini LLC
Reason: Undeclared peanuts
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Food
Class I
Ongoing
Grade A Brown In-shell Chicken eggs packaged in the following configurations: 1. Simple Truth, Natural Cage Free Grain Fed, Medium, 12 Eggs, Net Wt 21 oz (1lb 5oz) 596g,...
Firm: MIDWEST POULTRY SERVC C/O H & LELECTRIC
Reason: Possible Salmonella Enteritidis
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Drugs
Class I
Ongoing
Kian Pee Wan Capsules, 30-count bottles
Firm: Buy-Herbal
Reason: Marketed Without an Approved NDA/ANDA: Product contains undeclared drug ingredients dexamethasone and cyproheptadine.
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Drugs
Class I
Ongoing
Glutathione (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 inj...
Firm: Victory Medical Center Pharmacy
Reason: Microbial Contamination of Sterile Products - out of specifications results were obtained for bacterial endotoxin.
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Drugs
Class I
Ongoing
Optiray Imaging Bulk Package-350, Ioversol Injection 74%, 350 mg/mL Organically Bound Iodine, 500 mL Multiple-Dose Vial, Rx only, Sterile Solution, Manufactured by: Liebe...
Firm: Liebel-Flarsheim Company LLC
Reason: Presence of Particulate Matter: comprising polyethylene and other plastic materials, stainless steel and glass.
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Devices
Class I
Ongoing
Brand Name: Elevaris/Spectra Medical Devices Product Name: Sodium Chloride Injection, 0.9%, USP 10mL Ampule Model/Catalog Number: AMPUL10MLK. Sodium Chloride Flush for IV...
Firm: Spectra Medical Devices, Llc
Reason: Manufacturing firm, Huons, was cited for issues regarding product quality and sterility assurance. If the product sterility is compromised, patients may be exposed to microorganisms, endotoxins, or foreign matt...
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Food
Class II
Ongoing
Vodka Tomato Sauce, NET WT. 24 oz / 680g, glass jar packed 12 jars in a carton.
Firm: SHEANDRO LLC
Reason: Label declares cream and cheese, but Milk is not declared
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Drugs
Class II
Ongoing
SILDENAFIL CITRATE USP, 0.100 KG, 100 gm-bag Net Wt, RX ONLY "FOR Prescription Compounding Only", Shoolin Pharma Chem LLP, Block/Survey no 408, B/H Ratnamani Tubes, Near...
Firm: Shoolin Pharma Chem LLP
Reason: CGMP Deviations:Noted during FDA inspection
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Drugs
Class II
Ongoing
SEMAGLUTIDE 7.5mg (5mg/mL), Glycine 7.5 mg (5mg/mL), 1.5 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, APOLLO care, 3801 Mojave Ct, Ste 102, Colum...
Firm: Apollo Care, LLC
Reason: Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material
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Drugs
Class II
Ongoing
SEMAGLUTIDE 12.5MG (2.5MG/mL), 5 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, APOLLO care, 3801 Mojave Ct, Ste 102, Columbia, MO 65202. NDC 71170...
Firm: Apollo Care, LLC
Reason: Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material
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Drugs
Class II
Ongoing
SEMAGLUTIDE 2.25MG (0.9 mg/mL), 2.5 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, APOLLO care, 3801 Mojave Ct, Ste 102, Columbia, MO 65202 NDC 711...
Firm: Apollo Care, LLC
Reason: Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material
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Drugs
Class II
Ongoing
CLINDAMYCIN PALMITATE HYDROCHLORIDE FOR ORAL SOLUTION, USP, 75 mg/5 mL, Rx Only, 100 mL, Distributed by: Avet Pharmaceuticals Inc., East Brunswick, NJ 08816, NDC 23155-60...
Firm: Heritage Pharmaceuticals Inc
Reason: Presence of Foreign Substance: presence of particles and white flakes in the reconstituted bottles.
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Drugs
Class II
Ongoing
SEMAGLUTIDE 2.5mg (1mg/mL), Glycine 12.5 mg (5mg/mL), 2.5 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, APOLLO care, 3801Mojave Ct, Ste 102, Colum...
Firm: Apollo Care, LLC
Reason: Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material
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Drugs
Class II
Ongoing
SEMAGLUTIDE 6.75mg (4.5 mg/mL), 1.5 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, APOLLO care, 3801 Mojave Ct, Ste 102, Columbia, MO 65202 NDC 711...
Firm: Apollo Care, LLC
Reason: Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material
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Drugs
Class II
Ongoing
SEMAGLUTIDE 0.9mg (0.9 mg/mL), 1 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, APOLLO care, 3801 Mojave Ct, Ste 102, Columbia, MO 65202. NDC 71170...
Firm: Apollo Care, LLC
Reason: Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material
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Drugs
Class II
Ongoing
CLEAR EYES Maximum Itchy Eye Relief, 0.5 fl oz (15 mL) per dropper bottle, Sterile, Dist. by Medtech Products Inc., Tarrytown, NY 10591, a Prestige Consumer Healthcare Co...
Firm: Prestige Brands Holdings
Reason: Lack of assurance of sterility. The recall is due to potential contamination
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Devices
Class II
Ongoing
GORE VIABIL Short Wire Biliary Endoprosthesis, Model No. VSWVN1010. Flexible, self-expanding endoprosthesis designed to maintain luminal patency of the common bile duct w...
Firm: W L Gore & Associates, Inc.
Reason: 10 mm diameter x 7 cm with transmural drainage holes (VSWVH1006) incorrectly labeled as 10 mm diameter x 10 cm length devices without transmural drainage holes (VSWVN1010).
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Devices
Class II
Ongoing
Cardinal Health Presource Kits: 1) ENT TRAY , Catalog Number: 24-0726A; 2) KIT,SINUS , Catalog Number: PE13SPAJA; 3) KIT,SINUS , Catalog Number: PE13SPAJB; 4) KIT, SINUS...
Firm: Cardinal Health 200, LLC
Reason: Procedure kits contain MEDICOM Ritmed Neurological Sponges that were recalled due to unexpected variability in endotoxin levels.
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Devices
Class II
Ongoing
V-Loc 180 Absorbable Wound Closure Device BOX BEDSIDE STAPLING IS KING BOX06614V4 BOX BY PASS FINAL BOX07405V1 BOX BYPASS CARDON BOX01056V2 BOX BYPASS DR LAGAE BOX01482V2...
Firm: Covidien, LP
Reason: Product may contain a perforation or tear in the sterile barrier packaging. This issue may result in biocontamination of the sterile sutures, which may lead to infection, loss of vision if in ophthalmic utiliza...
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Devices
Class II
Ongoing
BOBBY Balloon Guide Catheter REF: BOB-895-CN BOB-895-EMEA BOB-895-EMEA-AL BOB-895-US MV-BGA01095 For use in facilitating the insertion and guidance of an intravascular ca...
Firm: MICROVENTION INC.
Reason: Due to an increase rate of balloon pinhole defects.
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Devices
Class II
Ongoing
Cardinal Health Presource Kits: 1) HARMONIZED SPINE VCH PHC PACK , Catalog Number: SOP30SPBCC
Firm: Cardinal Health 200, LLC
Reason: Procedure kits contain MEDICOM Ritmed Neurological Sponges that were recalled due to unexpected variability in endotoxin levels.
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Devices
Class II
Ongoing
Medline Micro-Kill Bleach Germicidal Bleach Wipes, 12" x 12", 110 Count Bag, Product Number MSC351450BG4
Firm: Medline Industries, LP
Reason: Medline Micro-Kill Bleach Germicidal Bleach Wipes may exhibit a reduction in bleach concentration to levels below specification prior to the end of the labeled 12-month shelf life. Reduced bleach concentration...
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Devices
Class II
Ongoing
Cardinal Health Presource Kits: 1) KIT, MER NEURO BACK , Catalog Number: PN33NBMYD; 2) KIT,CHP BASIC NEURO , Catalog Number: PN36NBCH4; 3) KIT,CHP BASIC NEURO , Catalog N...
Firm: Cardinal Health 200, LLC
Reason: Procedure kits contain MEDICOM Ritmed Neurological Sponges that were recalled due to unexpected variability in endotoxin levels.
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Devices
Class II
Ongoing
Allura Xper FD. Model Numbers: 722026, 722027, 722028, 722029, 722035, 722038, 722039, 722058. Interventional fluoroscopic x-ray system.
Firm: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Reason: Firmware issue potentially leading to loss of geometry movements.
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Devices
Class II
Ongoing
GLIDESHEATH SLENDER A-KIT 6F 10CM .021GW. 5 units per box. Product Code: 60-1060. The Glidesheath Slender is used to facilitate placing a catheter through the skin into t...
Firm: Terumo Medical Corporation
Reason: Product was packaged with the 0.025 guidewire instead of the 0.021 guidewire.
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Devices
Class II
Ongoing
Medline Micro-Kill Bleach Germicidal Bleach Wipes, 12" x 12", 110 Count, Product Number MSC351450AN
Firm: Medline Industries, LP
Reason: Medline Micro-Kill Bleach Germicidal Bleach Wipes may exhibit a reduction in bleach concentration to levels below specification prior to the end of the labeled 12-month shelf life. Reduced bleach concentration...
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Devices
Class II
Ongoing
Medline Micro-Kill Bleach Germicidal Bleach Wipes, 6" x 5", 150 count, Product Number MSC351410AN
Firm: Medline Industries, LP
Reason: Medline Micro-Kill Bleach Germicidal Bleach Wipes may exhibit a reduction in bleach concentration to levels below specification prior to the end of the labeled 12-month shelf life. Reduced bleach concentration...
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Food
Not Yet Classified
Ongoing
MARKON BLEND LETT/ROM 80/20 WITH SEP BAGGIES 4/5# Iceberg, Romaine, Carrots, Red Cabbage products.
Firm: Taylor Farms de Mexico S. de R.L. de C.V.
Reason: Potential Cyclospora contamination.
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Food
Class III
Ongoing
Honeyville YELLOW COLOR 1 GALLON NFI: WATER, FD&C YELLOW #5, FD&C YELLOW #6, CITRIC ACID, AND SODIUM BENZOATE. MANUFACTURED FOR: HONEYVILLE, INC. RANCHO CUCAMONGA, CA 917...
Firm: FlavorsandColor.Com
Reason: Undeclared Red #40.
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