Vereinigte Staaten Recalls
Verbraucherrückrufe von FDA, CPSC, NHTSA und USDA FSIS.
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 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 FoodBlackstone Parmesan Ranch Seasoning, Net Wt 7.3 oz (207g). UPC 7 17604-04106 2. Manufactured for North Atlantic Imports, LLC, Logan, UT 84321.
Blackstone Parmesan Ranch Seasoning, Net Wt 7.3 oz (207g). UPC 7 17604-04106 2. Manufactured for North Atlantic Imports, LLC, Logan, UT 84321.
Product was made with milk powder recalled by the supplier due to Salmonella contamination.
FDA FoodGHIRARDELLI SWEET GROUND POWDER WHITE CHOCOLATE FLAVORED NET WT 50oz (3lbs 2oz) 1.41kg Distributed by Ghirardelli Chocolate Company, San Leandro, CA 94578, U.S.A. UPC: 747599620386
GHIRARDELLI SWEET GROUND POWDER WHITE CHOCOLATE FLAVORED NET WT 50oz (3lbs 2oz) 1.41kg Distributed by Ghirardelli Chocolate Company, San Leandro, CA 94578, U.S.A. UPC: 747599620386
Potential contamination with Salmonella.
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 FoodGHIRARDELLI PERFECTLY PREMIUM FRAPPE MIX 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: 747599662119
GHIRARDELLI PERFECTLY PREMIUM FRAPPE MIX 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: 747599662119
Potential contamination with Salmonella.
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 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 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 Food1P Original Smokehouse Unit for 300 lbs. of Meat, Part #: 180002964. Net Wt 15.10 lbs (6.85kg). PS Seasoning & Spices 216W Pleasant St Iron Ridge, WI 53035.
1P Original Smokehouse Unit for 300 lbs. of Meat, Part #: 180002964. Net Wt 15.10 lbs (6.85kg). 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 DrugsPrimidone Tablets USP, 250mg, 100-count bottle, Rx only, Distributed by: Lannett Company, Inc., Philadelphia, PA 19136, NDC 0527-1231-01.
Primidone Tablets USP, 250mg, 100-count bottle, Rx only, Distributed by: Lannett Company, Inc., Philadelphia, PA 19136, NDC 0527-1231-01.
Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.
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 DrugsPrimidone Tablets, USP, 250 mg, 100-count bottle, RX only, Manufactured by: Lannett Company, Inc., Marketed by: GSMS, Incorporated, Camarillo, CA 93012. NDC 51407-638-01
Primidone Tablets, USP, 250 mg, 100-count bottle, RX only, Manufactured by: Lannett Company, Inc., Marketed by: GSMS, Incorporated, Camarillo, CA 93012. NDC 51407-638-01
Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.
FDA FoodSolina 6036786 Instant Country Gravy Seasoning, 40lb bag
Solina 6036786 Instant Country Gravy Seasoning, 40lb bag
potential to be contaminated with 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 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 FoodSea Moss Tonic 16 oz and 32. oz.
Sea Moss Tonic 16 oz and 32. oz.
May be under-processed resulting in growth of Clostridium botulinum and lists health claims.
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.
FDA FoodSolina 6036554 Parmesan Breadstick Sauce Seasoning, 40lb bag
Solina 6036554 Parmesan Breadstick Sauce Seasoning, 40lb bag
potential to be contaminated with Salmonella
FDA DrugsGas-X, Simethicone 125 mg/ ANTIGAS, 120 SoftGels, Distributed by: Haleon, Warren, NJ 07059, UPC: 3 00674 35041 9.
Gas-X, Simethicone 125 mg/ ANTIGAS, 120 SoftGels, Distributed by: Haleon, Warren, NJ 07059, UPC: 3 00674 35041 9.
Labeling: Not Elsewhere Classified- Incomplete inactive ingredient information on the carton labeling.
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 DrugsLiraglutide Injection, 18 mg/3 mL (6 mg/mL), Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Naples, FL 34108, Manufactured by: Lupin Limited, Nagpur 441108, INDIA, a) 2 Pens- NDC 70748-346-02; b) 3 Pens - NDC 70748-346-03.
Liraglutide Injection, 18 mg/3 mL (6 mg/mL), Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Naples, FL 34108, Manufactured by: Lupin Limited, Nagpur 441108, INDIA, a) 2 Pens- NDC 70748-346-02; b) 3 Pens - NDC 70748-346-03.
Presence of particulate matter: a white thread-like structure in the cartridge
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.