États-Unis Recalls

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 Company. NDC: 67172-999-01 UPC 6 78112 65920 3

Lack of assurance of sterility. The recall is due to potential contamination

SEMAGLUTIDE 10mg (5mg/mL), Glycine 10 mg (5mg/mL), 2 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, APOLLO care, 3801 Mojave Ct, Ste 102, Columbia, MO 65202. NDC 71170-722-02

Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material

Cefazolin 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 60015, USA, NDC 0338-3508-41.

Presence of Particulate Matter

Medline Micro-Kill Bleach Germicidal Bleach Wipes, 12" x 12", 110 Count Bag, Product Number MSC351450BG4

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 may compromise the effectiveness of disinfection, potentially allowing for the survival and persistence of pathogenic microorganisms.

Cross Valley Farms LETTUCE SALAD MIX 4/5# Cross Valley Farms LETTUCE SALAD WITH SEP BAG 4/5# Iceberg, Carrots, Red Cabbage products.

Potential Cyclospora contamination.

ProNephro AKI (NGAL) Reagent Kit (100 tests). IVD Acute Kidney Injury Test System.

The use of a non-validated rework process for assay reagents which could lead to missed diagnosis of renal disease, inappropriate treatment decisions, or inappropriate monitoring of renal disease in intended users.

Vodka Tomato Sauce, NET WT. 24 oz / 680g, glass jar packed 12 jars in a carton.

Label declares cream and cheese, but Milk is not declared

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 71170-495-05

Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material

PEAK LETTUCE SHRED 1/8" 4/5# Iceberg only products.

Potential Cyclospora contamination.

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 71170-821-01

Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material

Endo-Model, Replacement Set, Tibial Plateau, right/left, L, UHMWPE, CoCrMo, Rotating Hinge Item Number 15-0027/16

The affected Endo-Model replacement set for a Rotating Hinge tibial plateau incorrectly contains a Pure Hinge plateau. The incorrect plateau could lead to a prolonged or modified surgery as the plateau cannot be inserted and an alternative product would be needed. If the incorrect plateau were to be implanted, this is associated with increased risk of wear, which could result in a reduced standing time of the implant.

Cibus Fresh, Sprig & Sprout, and Jack & Olive brand Garden Salad, 7.75oz clear plastic container, UPC 810028250253

Possible Cyclospora Contamination

GM Helix Implant, Endosseous Dental Implant Article No. 109.984

There may be a mismatch between the implant contained inside the packaging and the information described on the outer carton label. If the the incorrect implant is installed, the issue could cause bone compression or difficulty during installation in situations where there is sufficient bone volume

Cardinal Health Presource Kits: 1) NEWNAN SMR PACK, Catalog Number: SEN21SPPMB

Procedure kits contain MEDICOM Ritmed Neurological Sponges that were recalled due to unexpected variability in endotoxin levels.

Cardinal Health Presource Kits: 1) BASIC PACK , Catalog Number: SBA73BPGCA; 2) SPINE PACK , Catalog Number: SNE11SPHKC; 3) SPINE PACK , Catalog Number: SNE11SPHKD; 4) CRANIOTOMY PACK , Catalog Number: SNE12BS01B

Procedure kits contain MEDICOM Ritmed Neurological Sponges that were recalled due to unexpected variability in endotoxin levels.

TADALAFIL USP, 1.00 KG, 1KG(1000gm)-bag, Rx only, "For Prescription Compounding Only", Shoolin Pharma Chem LLP, Block/Survey no 408, B/H Ratnamani Tubes, Near Maruti Inox, Indrad, Kadi, Mahesania, Gujarat, 382715, India, (CAS NO 171596-29-5), NDC 85702-001-08

CGMP Deviations:Noted during FDA inspection

PEAK LETTUCE SALAD W/BAG 4/5# Iceberg, Carrots, Red Cabbage products.

Potential Cyclospora contamination.

Updated – Dreyer’s Grand Ice Cream, Inc. Issues Voluntary Recall on Select Outshine Fruit Bars Due to Possible Foreign Matter Contamination

L-Nutra Issues Allergy Alert on Undeclared Tree Nuts in Prolon Brand Apulian Almond & Cocoa Spread

The Heil Co. - Ladder Bolt May Damage CNG Cylinders

A damaged CNG tank can leak fuel, increasing the risk of a fire.

Ring Power Corporation - Cracked Weld May Cause Pole Guide Arm to Fall

Without a retaining pin, the pole guide arm may fall, increasing the risk of injury to people around the truck.

The Heil Co. - Ladder Bolt May Damage CNG Cylinders

A damaged CNG tank can leak fuel, increasing the risk of a fire.

Holley Performance Products - Loss of Throttle Control

A loss of throttle control increases the risk of a crash.

UPDATED: Oma's Pride Voluntarily Recalls One Lot of Woof Complete Canine Chicken Recipe (6 Lb Bag) Because of Possible Salmonella Health Risk