3 loaded records
3 Class I
3 ongoing
Food
Clover Hill Dairy, LLC
Clover Hill Dairy LLP, mild cheese variety (Snack Pack Assorted Regular Mild Stix White Colby,... | Clover Hill Dairy LLP, Pepper Jack Cheese Varieties (Jalapeno Cheddar, Pepper Jack, Sizzlin Col... | Clover Hill Dairy LLP, Mild Cheese Variety (Yummy Cheddar, White Cheddar, White Colby, Monterey...
- Food: Product contaminated with Listeria monocytogenes. openFDA source
- Food: Product contaminated with Listeria monocytogenes. openFDA source
- Food: Product contaminated with Listeria monocytogenes. openFDA source
2 loaded records
2 Class I
2 ongoing
Food
MIDWEST POULTRY SERVC C/O H & LELECTRIC
Grade A White In-shell Chicken eggs packaged in the following configurations: 1. Kroger, Medium... | Grade A Brown In-shell Chicken eggs packaged in the following configurations: 1. Simple Truth,...
1 loaded record
1 Class I
1 ongoing
Food
Bazzini LLC
Dark Chocolate Coconut Almond Bites, 3.17oz, Plastic Pouches, 10 Packages per case.
1 loaded record
1 Class I
1 ongoing
Drugs
Buy-Herbal
Kian Pee Wan Capsules, 30-count bottles
- Drugs: Marketed Without an Approved NDA/ANDA: Product contains undeclared drug ingredients dexamethasone and cyproheptadine. openFDA source
1 loaded record
1 Class I
1 ongoing
Food
FACTORY6, INC.
Zen Principle Naturals Moringa Leaf Powder dietary supplement, 900mg capsules, 180 capsules per...
- Food: Possible Salmonella in Moringa Leaf Powder product. openFDA source
1 loaded record
1 Class I
1 ongoing
Food
La Colonia Foods Llc
Selectos Latinos Requeson Mexicano Mexican Cottage Cheese, Net Weight 16 oz, packed into retail...
- Food: Products may be contaminated with Listeria monocytogenes. openFDA source
1 loaded record
1 Class I
1 ongoing
Drugs
Liebel-Flarsheim Company LLC
Optiray Imaging Bulk Package-350, Ioversol Injection 74%, 350 mg/mL Organically Bound Iodine, 5...
- Drugs: Presence of Particulate Matter: comprising polyethylene and other plastic materials, stainless steel and glass. openFDA source
1 loaded record
1 Class I
1 ongoing
Food
M.G. Foods, Inc.
Spicy Breakfast Burrito sold under the following brand names: FRESH & READY FOODS Spicy Breakfa...
- Food: Undeclared Soy. The firm received complaints of sausage in the burritos. Upon review the firm discovered the sausage contains soy which is n... openFDA source
1 loaded record
1 Class I
1 ongoing
Devices
Spectra Medical Devices, Llc
Brand Name: Elevaris/Spectra Medical Devices Product Name: Sodium Chloride Injection, 0.9%, USP...
- Devices: Manufacturing firm, Huons, was cited for issues regarding product quality and sterility assurance. If the product sterility is compromised,... openFDA source
1 loaded record
1 Class I
1 ongoing
Drugs
Victory Medical Center Pharmacy
Glutathione (MDV), 200 mg/mL, 30 mL vial, each mL contains Glutathione 200 mg, Ascorbic Acid 20...
- Drugs: Microbial Contamination of Sterile Products - out of specifications results were obtained for bacterial endotoxin. openFDA source
6 loaded records
0 Class I
6 ongoing
Drugs
Apollo Care, LLC
SEMAGLUTIDE 7.5mg (5mg/mL), Glycine 7.5 mg (5mg/mL), 1.5 mL Sterile Multi-Dose Vial, Rx Only, F... | SEMAGLUTIDE 12.5MG (2.5MG/mL), 5 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injectio... | SEMAGLUTIDE 2.25MG (0.9 mg/mL), 2.5 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injec... | SEMAGLUTIDE 2.5mg (1mg/mL), Glycine 12.5 mg (5mg/mL), 2.5 mL Sterile Multi-Dose Vial, Rx Only,... | SEMAGLUTIDE 6.75mg (4.5 mg/mL), 1.5 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injec... | SEMAGLUTIDE 0.9mg (0.9 mg/mL), 1 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injectio...
- Drugs: Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material openFDA source
- Drugs: Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material openFDA source
- Drugs: Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material openFDA source
- Drugs: Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material openFDA source
- Drugs: Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material openFDA source
- Drugs: Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material openFDA source
3 loaded records
0 Class I
3 ongoing
Devices
Cardinal Health 200, LLC
Cardinal Health Presource Kits: 1) ENT TRAY , Catalog Number: 24-0726A; 2) KIT,SINUS , Catalog... | Cardinal Health Presource Kits: 1) HARMONIZED SPINE VCH PHC PACK , Catalog Number: SOP30SPBCC | Cardinal Health Presource Kits: 1) KIT, MER NEURO BACK , Catalog Number: PN33NBMYD; 2) KIT,CHP...
- Devices: Procedure kits contain MEDICOM Ritmed Neurological Sponges that were recalled due to unexpected variability in endotoxin levels. openFDA source
- Devices: Procedure kits contain MEDICOM Ritmed Neurological Sponges that were recalled due to unexpected variability in endotoxin levels. openFDA source
- Devices: Procedure kits contain MEDICOM Ritmed Neurological Sponges that were recalled due to unexpected variability in endotoxin levels. openFDA source
3 loaded records
0 Class I
3 ongoing
Devices
Medline Industries, LP
Medline Micro-Kill Bleach Germicidal Bleach Wipes, 12" x 12", 110 Count Bag, Product Number MSC... | Medline Micro-Kill Bleach Germicidal Bleach Wipes, 12" x 12", 110 Count, Product Number MSC3514... | Medline Micro-Kill Bleach Germicidal Bleach Wipes, 6" x 5", 150 count, Product Number MSC351410...
- Devices: Medline Micro-Kill Bleach Germicidal Bleach Wipes may exhibit a reduction in bleach concentration to levels below specification prior to the... openFDA source
- Devices: Medline Micro-Kill Bleach Germicidal Bleach Wipes may exhibit a reduction in bleach concentration to levels below specification prior to the... openFDA source
- Devices: Medline Micro-Kill Bleach Germicidal Bleach Wipes may exhibit a reduction in bleach concentration to levels below specification prior to the... openFDA source
1 loaded record
0 Class I
1 ongoing
Devices
Covidien, LP
V-Loc 180 Absorbable Wound Closure Device BOX BEDSIDE STAPLING IS KING BOX06614V4 BOX BY PASS F...
- Devices: Product may contain a perforation or tear in the sterile barrier packaging. This issue may result in biocontamination of the sterile sutures... openFDA source
1 loaded record
0 Class I
1 ongoing
Food
FlavorsandColor.Com
Honeyville YELLOW COLOR 1 GALLON NFI: WATER, FD&C YELLOW #5, FD&C YELLOW #6, CITRIC ACID, AND S...
1 loaded record
0 Class I
1 ongoing
Drugs
Heritage Pharmaceuticals Inc
CLINDAMYCIN PALMITATE HYDROCHLORIDE FOR ORAL SOLUTION, USP, 75 mg/5 mL, Rx Only, 100 mL, Distri...
- Drugs: Presence of Foreign Substance: presence of particles and white flakes in the reconstituted bottles. openFDA source
1 loaded record
0 Class I
1 ongoing
Devices
MICROVENTION INC.
BOBBY Balloon Guide Catheter REF: BOB-895-CN BOB-895-EMEA BOB-895-EMEA-AL BOB-895-US MV-BGA0109...
- Devices: Due to an increase rate of balloon pinhole defects. openFDA source
1 loaded record
0 Class I
1 ongoing
Devices
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Allura Xper FD. Model Numbers: 722026, 722027, 722028, 722029, 722035, 722038, 722039, 722058....
- Devices: Firmware issue potentially leading to loss of geometry movements. openFDA source
1 loaded record
0 Class I
1 ongoing
Drugs
Prestige Brands Holdings
CLEAR EYES Maximum Itchy Eye Relief, 0.5 fl oz (15 mL) per dropper bottle, Sterile, Dist. by Me...
- Drugs: Lack of assurance of sterility. The recall is due to potential contamination openFDA source
1 loaded record
0 Class I
1 ongoing
Food
SHEANDRO LLC
Vodka Tomato Sauce, NET WT. 24 oz / 680g, glass jar packed 12 jars in a carton.
- Food: Label declares cream and cheese, but Milk is not declared openFDA source
1 loaded record
0 Class I
1 ongoing
Drugs
Shoolin Pharma Chem LLP
SILDENAFIL CITRATE USP, 0.100 KG, 100 gm-bag Net Wt, RX ONLY "FOR Prescription Compounding Only...
1 loaded record
0 Class I
1 ongoing
Food
Taylor Farms de Mexico S. de R.L. de C.V.
MARKON BLEND LETT/ROM 80/20 WITH SEP BAGGIES 4/5# Iceberg, Romaine, Carrots, Red Cabbage produc...
1 loaded record
0 Class I
1 ongoing
Devices
Terumo Medical Corporation
GLIDESHEATH SLENDER A-KIT 6F 10CM .021GW. 5 units per box. Product Code: 60-1060. The Glideshea...
- Devices: Product was packaged with the 0.025 guidewire instead of the 0.021 guidewire. openFDA source
1 loaded record
0 Class I
1 ongoing
Devices
W L Gore & Associates, Inc.
GORE VIABIL Short Wire Biliary Endoprosthesis, Model No. VSWVN1010. Flexible, self-expanding en...
- Devices: 10 mm diameter x 7 cm with transmural drainage holes (VSWVH1006) incorrectly labeled as 10 mm diameter x 10 cm length devices without transm... openFDA source