États-Unis Recalls
Rappels de sécurité de la FDA, CPSC, NHTSA et de l’USDA FSIS.
FDA FoodSouthern Style Nuts Hunter Mix 30 oz plastic jar UPC 085839916302, 4 jars per case
Southern Style Nuts Hunter Mix 30 oz plastic jar UPC 085839916302, 4 jars per case
potential presence of Salmonella
FDA DevicesMedtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94965; Cardiopulmonary bypass vascular catheter
Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94965; Cardiopulmonary bypass vascular catheter
Certain lots of product have the potential for a sterile barrier breach.
FDA DevicesAzurion system; System Code Description (Model Numbers): Azurion 3 M12 (722063), Azurion 3 M15 (722064), Azurion 7 B12 (722067), Azurion 7 B20 (722068), Azurion 7 M12 (722078), Azurion 7 M20 (722079, 722224).
Azurion system; System Code Description (Model Numbers): Azurion 3 M12 (722063), Azurion 3 M15 (722064), Azurion 7 B12 (722067), Azurion 7 B20 (722068), Azurion 7 M12 (722078), Azurion 7 M20 (722079, 722224).
The deaeration hose in X-ray tube cooling units type CU3101, manufactured between February 2016 and May 2020, may degrade over time, potentially resulting in oil leakage. Oil leakage may affect the cooling performance of the X-ray tube. When the oil flow drops below a certain threshold, the system automatically switches to low-dose fluoroscopy and displays the message Low load fluoroscopy flavor selected: Tube cooler problem . This condition cannot be resolved by restarting the system.
FDA DrugsErythromycin Tablets, USP, 500 mg, 30 tablets per bottle, Rx only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534; (NDC 70710-1048-3).
Erythromycin Tablets, USP, 500 mg, 30 tablets per bottle, Rx only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534; (NDC 70710-1048-3).
CGMP Deviations; presence of N-Nitroso-Desmethyl-Erythromycin above the recommended acceptable intake limit
FDA DrugsVitamin B-Complex, Vitamin C & Folic Acid Dietary Supplement Oral Liquid, Contains: Folic Acid 799 mcg/5mL, Delivers 5 mL per oral syringe, (Nephronex), Mfg By: LLORENS; Pkg by: Safecor, Columbus, OH. NDC 54859-0516-08
Vitamin B-Complex, Vitamin C & Folic Acid Dietary Supplement Oral Liquid, Contains: Folic Acid 799 mcg/5mL, Delivers 5 mL per oral syringe, (Nephronex), Mfg By: LLORENS; Pkg by: Safecor, Columbus, OH. NDC 54859-0516-08
Presence of a Foreign Substance; black particles observed in liquid
FDA FoodGood & Gather Mexican Street Corn Trail Mix 8 oz bag UPC 085239270240, 8 bags per case
Good & Gather Mexican Street Corn Trail Mix 8 oz bag UPC 085239270240, 8 bags per case
potential presence of Salmonella
FDA Food1P Jalapeno Heat Unit for 300 lbs of Meat, Part #: 180002945. Net Wt 18 lbs (8.20kg). PS Seasoning & Spices 216W Pleasant St Iron Ridge, WI 53035.
1P Jalapeno Heat Unit for 300 lbs of Meat, Part #: 180002945. Net Wt 18 lbs (8.20kg). PS Seasoning & Spices 216W Pleasant St Iron Ridge, WI 53035.
Product was made with milk powder recalled by the supplier due to Salmonella contamination.
FDA DevicesMedtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94665; Cardiopulmonary bypass vascular catheter
Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94665; Cardiopulmonary bypass vascular catheter
Certain lots of product have the potential for a sterile barrier breach.
FDA DrugsMG217 Multi-Symptom Treatment Cream & Skin Protectant (colloidal oatmeal 2%), NET WT 6 oz (170 g), Manufactured by: Pharmacal 1 Pharmacal Way, P.O. Box 198, Jackson, WI 53037.
MG217 Multi-Symptom Treatment Cream & Skin Protectant (colloidal oatmeal 2%), NET WT 6 oz (170 g), Manufactured by: Pharmacal 1 Pharmacal Way, P.O. Box 198, Jackson, WI 53037.
Microbial Contamination of Non-Sterile Products: confirmed presence of Staphylococcus Aureus.
FDA FoodJoint Nourish. Dosage:2 tablespoons (30mL). Liquid. For Oral use. Packaging: Plastic Bottle. Net Volume:480 ml. Firm Address: VitaminAlly LLC Chandler, AZ 85225.
Joint Nourish. Dosage:2 tablespoons (30mL). Liquid. For Oral use. Packaging: Plastic Bottle. Net Volume:480 ml. Firm Address: VitaminAlly LLC Chandler, AZ 85225.
Deviations from current Good Manufacturing Practices (cGMP) that could lead to bacterial pathogen contamination and possible C. Botulinum concerns.
FDA FoodPure Shilajit Tonic 16 oz and 32 oz
Pure Shilajit Tonic 16 oz and 32 oz
May be under-processed resulting in growth of Clostridium botulinum and lists health claims.
FDA FoodSolina 6036554 Parmesan Breadstick Sauce Seasoning, 40lb bag
Solina 6036554 Parmesan Breadstick Sauce Seasoning, 40lb bag
potential to be contaminated with Salmonella
FDA FoodSquirrel Brand Travelers Mix 16 oz can UPC 07223899166, 12 cans per case
Squirrel Brand Travelers Mix 16 oz can UPC 07223899166, 12 cans per case
potential presence of Salmonella
FDA FoodSolina 6036786 Instant Country Gravy Seasoning, 40lb bag
Solina 6036786 Instant Country Gravy Seasoning, 40lb bag
potential to be contaminated with Salmonella
FDA FoodLiposomal Collagen Booster. Dosage: 3mL Liquid. Packaging: Aluminum bottle. 90 ml. Firm Address: Vitaminally LLC Chandler, AZ 85225.
Liposomal Collagen Booster. Dosage: 3mL Liquid. Packaging: Aluminum bottle. 90 ml. Firm Address: Vitaminally LLC Chandler, AZ 85225.
Deviations from current Good Manufacturing Practices (cGMP) that could lead to bacterial pathogen and possible C. Botulinum concerns.
FDA FoodGHIRARDELLI PERFECTLY PREMIUM FRAPPE MIX WHITE MOCHA NET WT 50oz (3lbs 2oz) 1.42kg Ingredients: *** nonfat dry milk *** Distributed by Ghirardelli Chocolate Company, San Leandro, CA 94578, U.S.A. UPC: 747599662096
GHIRARDELLI PERFECTLY PREMIUM FRAPPE MIX WHITE MOCHA NET WT 50oz (3lbs 2oz) 1.42kg Ingredients: *** nonfat dry milk *** Distributed by Ghirardelli Chocolate Company, San Leandro, CA 94578, U.S.A. UPC: 747599662096
Potential contamination with Salmonella.
FDA DevicesSilastic Foley Catheters Silastic Brand Foley Catheter 30cc REF: 33416 33418 33420 33422 33424 Silastic Brand Foley Catheter 5cc REF: 33614 33616 33618 33620 33622 33624
Silastic Foley Catheters Silastic Brand Foley Catheter 30cc REF: 33416 33418 33420 33422 33424 Silastic Brand Foley Catheter 5cc REF: 33614 33616 33618 33620 33622 33624
Due to stain present on the surface of affected foley catheters.
FDA FoodSquirrel Brand Town & Country Mix 16 oz can UPC 07223805251 and 7.5 oz can UPC 07223805450. 16 oz 12 cans per case. 7.5 oz 6 cans per case
Squirrel Brand Town & Country Mix 16 oz can UPC 07223805251 and 7.5 oz can UPC 07223805450. 16 oz 12 cans per case. 7.5 oz 6 cans per case
potential presence of Salmonella
FDA FoodFisher Tex Mex Trail Mix 30 oz plastic jar UPC 070690275941, 6 jars per case
Fisher Tex Mex Trail Mix 30 oz plastic jar UPC 070690275941, 6 jars per case
potential presence of Salmonella
FDA FoodLiposomal Women's Liquid Multivitamin Drops with Iron. Dosage: 3mL Liquid. Packaging: Aluminum bottle. 90 ml. Firm Address: Vitaminally LLC Chandler, AZ 85225.
Liposomal Women's Liquid Multivitamin Drops with Iron. Dosage: 3mL Liquid. Packaging: Aluminum bottle. 90 ml. Firm Address: Vitaminally LLC Chandler, AZ 85225.
Deviations from current Good Manufacturing Practices (cGMP) that could lead to bacterial pathogen and possible C. Botulinum concerns.
FDA FoodC0017D Natural & Artificial White Cheddar Cheese Flavor, Net Weight: 50 lbs. bag. Item #: 8500101. For Further Processing. Fontana Flavors, Janesville, WI.
C0017D Natural & Artificial White Cheddar Cheese Flavor, Net Weight: 50 lbs. bag. Item #: 8500101. For Further Processing. Fontana Flavors, Janesville, WI.
Product was made with milk powder recalled by the supplier due to Salmonella contamination.
FDA DrugsBusulfan Injection, 60 mg per 10 mL (6 mg per mL), 8x10 mL Single-Dose Vials, Rx only, Mfd. for Sagent Pharmaceuticals, Schaumburg, IL 60195, Made in Canada, NDC 25021-241-10.
Busulfan Injection, 60 mg per 10 mL (6 mg per mL), 8x10 mL Single-Dose Vials, Rx only, Mfd. for Sagent Pharmaceuticals, Schaumburg, IL 60195, Made in Canada, NDC 25021-241-10.
Failed Impurities/Degradation Specifications
FDA DrugsEstradiol Gel, 0.1%, 0.25 mg, 0.25 g per packet, 30 packets per carton, Rx only, Distributed by: ANI Pharmaceuticals, Inc., Baudette, MN 56623. NDC 70954-531-20
Estradiol Gel, 0.1%, 0.25 mg, 0.25 g per packet, 30 packets per carton, Rx only, Distributed by: ANI Pharmaceuticals, Inc., Baudette, MN 56623. NDC 70954-531-20
Defective Container; packets were found to be either empty or partially full.
FDA DevicesIntegris-Allura system; System Code Description (Model Numbers): Integris CV Cesar-Powerpack-Visub-Nicol (722030), Integris Allura 15 & 12 (monoplane) (722043), INTEGRIS Allura 15-12 (biplane) (722044), Integris-Allura 9 (722018), Integris-Allura 9 (Biplane) (722021), Integris CV Cesar-Powerpack (722030), Integris H5000 C / Allura 9C (722016);
Integris-Allura system; System Code Description (Model Numbers): Integris CV Cesar-Powerpack-Visub-Nicol (722030), Integris Allura 15 & 12 (monoplane) (722043), INTEGRIS Allura 15-12 (biplane) (722044), Integris-Allura 9 (722018), Integris-Allura 9 (Biplane) (722021), Integris CV Cesar-Powerpack (722030), Integris H5000 C / Allura 9C (722016);
The deaeration hose in X-ray tube cooling units type CU3101, manufactured between February 2016 and May 2020, may degrade over time, potentially resulting in oil leakage. Oil leakage may affect the cooling performance of the X-ray tube. When the oil flow drops below a certain threshold, the system automatically switches to low-dose fluoroscopy and displays the message Low load fluoroscopy flavor selected: Tube cooler problem . This condition cannot be resolved by restarting the system.