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FDA FoodYoyo Gummy Assorted Flavor, 2.8 Oz (80g) , Plastic Bag, 24 bags per case
Yoyo Gummy Assorted Flavor, 2.8 Oz (80g) , Plastic Bag, 24 bags per case
The products contain an unallowed color Carmoisine (E122) - Acid Red 14.
FDA DrugsVista Gel Hypromellose USP 0.3% w/v, Eye Drops Dry Eye Relief Lubricating Gel, 10 ml. (1/3 fl. oz), Wizcure Pharmaa PVT. LTD, H-881, Phase-3, RIICO Industrial Area, Bhiwadi-301019, India, Manufactured for and distributed by: hi-health, 15207 N. 75th Street, Suite #104, Scottsdale, AZ, 85260, NDC 77790-002-10.
Vista Gel Hypromellose USP 0.3% w/v, Eye Drops Dry Eye Relief Lubricating Gel, 10 ml. (1/3 fl. oz), Wizcure Pharmaa PVT. LTD, H-881, Phase-3, RIICO Industrial Area, Bhiwadi-301019, India, Manufactured for and distributed by: hi-health, 15207 N. 75th Street, Suite #104, Scottsdale, AZ, 85260, NDC 77790-002-10.
Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.
FDA FoodValley Springs 100% Natural Bottled Water. Fluoride Added. 1 Gal Net, 128 Fl. Oz. UPC 0 31193-01301 0. Bottled by Valley Springs/Artesian Gold, LLC, Portage WI 53901.
Valley Springs 100% Natural Bottled Water. Fluoride Added. 1 Gal Net, 128 Fl. Oz. UPC 0 31193-01301 0. Bottled by Valley Springs/Artesian Gold, LLC, Portage WI 53901.
Water was bottled under insanitary conditions.
FDA FoodYoyo Gummy Grape Plus Flavor, 2.8 Oz (80g) , Plastic Bag, 24 bags per case
Yoyo Gummy Grape Plus Flavor, 2.8 Oz (80g) , Plastic Bag, 24 bags per case
The products contain an unallowed color Carmoisine (E122) - Acid Red 14.
FDA DevicesOlympus Inner Sheath, Long; Model No. WA22017T. Inner sheath for urological and gynecological applications.
Olympus Inner Sheath, Long; Model No. WA22017T. Inner sheath for urological and gynecological applications.
Complaints of the ceramic tip of the resection sheath breaking have been received.
FDA FoodYO!MAN LETTUCE (SPICY FLAVOR); Ingredients: Lettuce, chili pepper, edible vegetable oil, salt, water, sugar, food additives (monosodium glutamate, potassium sorbate, streptoccoccus lactis, sodium dehydroacetate, sodium D-isoacsorbate, disodium ethylenediaminetetraacetatic acid, sodium metabisulphite, citric acid, lactic acid, glacial acetic acid, sucralose, xanthan gum, disodium 5'flavoring ribonucleotide), food flavors and fragrances; NET WT. 4.42oz.(125g); SHELF LIFE: 9 MONTHS; PRODUCT OF CHINA; Distributed by: Tengen USA Trading Corp 262 48th Street,Brooklyn,NY 11220; UPC: 4 895235 529626
YO!MAN LETTUCE (SPICY FLAVOR); Ingredients: Lettuce, chili pepper, edible vegetable oil, salt, water, sugar, food additives (monosodium glutamate, potassium sorbate, streptoccoccus lactis, sodium dehydroacetate, sodium D-isoacsorbate, disodium ethylenediaminetetraacetatic acid, sodium metabisulphite, citric acid, lactic acid, glacial acetic acid, sucralose, xanthan gum, disodium 5'flavoring ribonucleotide), food flavors and fragrances; NET WT. 4.42oz.(125g); SHELF LIFE: 9 MONTHS; PRODUCT OF CHINA; Distributed by: Tengen USA Trading Corp 262 48th Street,Brooklyn,NY 11220; UPC: 4 895235 529626
Product contains undeclared cyclamates.
FDA DevicesBrand Name: Hitachi Proton Beam Therapy REF: PROBEAT-CR
Brand Name: Hitachi Proton Beam Therapy REF: PROBEAT-CR
Software anomaly in the patient positioning system may result in positional discrepancy.
FDA DrugsCHNaO Fluorescein Sodium Ophthalmic Strips, USP 1mg, packaged as a) 100-count box, NDC 83851-100-10; b) 300-count box, NDC 83851-100-30. Manufactured by Wizcure Pharmaa PVT. LTD, H-681, Phase 3, RIICO Industrial Area, Bhiwadi- 301019 INDIA, Vistamerica USA, 20 Perkins Dr. Prescott, AZ 86301, Vistamerica USA, Made in India,
CHNaO Fluorescein Sodium Ophthalmic Strips, USP 1mg, packaged as a) 100-count box, NDC 83851-100-10; b) 300-count box, NDC 83851-100-30. Manufactured by Wizcure Pharmaa PVT. LTD, H-681, Phase 3, RIICO Industrial Area, Bhiwadi- 301019 INDIA, Vistamerica USA, 20 Perkins Dr. Prescott, AZ 86301, Vistamerica USA, Made in India,
Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.
FDA DrugsEptifibatide Injection, 75 mg/100 mL vial for weight-adjusted bolus dosing, 1x100 mL Single-dose Vial, For Intravenous Use Only, Rx Only, Manufactured by: Hainan Poly Pharm. Co., Ltd., Guilinyang Economic Development Area, Haikou, Hainan Province, China 571127; Distributed by: Slate Run Pharmaceuticals, LLC, Columbus, Ohio 43215. NDC Slate Run Carton Label: 70436-027-80; NDC ProRx Carton Label: 70436-163-80
Eptifibatide Injection, 75 mg/100 mL vial for weight-adjusted bolus dosing, 1x100 mL Single-dose Vial, For Intravenous Use Only, Rx Only, Manufactured by: Hainan Poly Pharm. Co., Ltd., Guilinyang Economic Development Area, Haikou, Hainan Province, China 571127; Distributed by: Slate Run Pharmaceuticals, LLC, Columbus, Ohio 43215. NDC Slate Run Carton Label: 70436-027-80; NDC ProRx Carton Label: 70436-163-80
Labeling: Not Elsewhere Classified. The carton for Eptifibatide Injection 75 mg/100 mL states 75 mg/100 mL vial for weight-adjusted bolus dosing. The approved statement is 75 mg/100 mL vial for weight-adjusted infusion.
FDA DevicesConvenience kits containing Tego Connectors: Medline DIALYSIS DRESSING CHANGE SKU EBSI1498 Medline DIALYSIS DRESSING CHANGE KIT SKU EBSI1107 EBSI1596 EBSI1781 EBSI1812 Centurion DIALYSIS/PHERESUS CVC DRSG CHANGE KIT SKU DT22630 Medline DIALYSIS/PHERESIS DRESSING CHANGE KIT SKU EBSI1470 Centurion VASCATH DRESSING CHANGE TRAY SKU DT22845
Convenience kits containing Tego Connectors: Medline DIALYSIS DRESSING CHANGE SKU EBSI1498 Medline DIALYSIS DRESSING CHANGE KIT SKU EBSI1107 EBSI1596 EBSI1781 EBSI1812 Centurion DIALYSIS/PHERESUS CVC DRSG CHANGE KIT SKU DT22630 Medline DIALYSIS/PHERESIS DRESSING CHANGE KIT SKU EBSI1470 Centurion VASCATH DRESSING CHANGE TRAY SKU DT22845
Affected lots may exhibit issues with the silicone seal on Tego Connectors included in kits. Issues include silicone seal doming and silicone seal tearing. These issues may result in an occluded fluid path identified by the inability of the user to inject or withdraw blood product with a syringe. Damaged seals may also result in delay in therapy or fluid leakage, interruption in therapy, exposure to biological contaminants or air infused into the body.
FDA DevicesMedline Convenience Kits: 1) NAIL KIT, Model Number: POD14214
Medline Convenience Kits: 1) NAIL KIT, Model Number: POD14214
Medline has identified that the manufacturer of the sterile saline wound wash may not have manufactured products to meet the minimum required sterility assurance level required for sterile products.
FDA DrugsVista Tears Polyethylene Glycol 400 0.4% w/v, Propylene Glycol 0.3% w/v Eye Drops, Dry Eye Relief, Lubricant Drops, Sterile 10 ml (1/3 fl. oz.), Manufactured by: RA/Drugs/ MFG/2019/196283, Omni Lens Pvt. Ltd. 5, Samrudhhi, Opposite:Sakar-III, Navrangpura, Ahmedabad-380014, INDIA. Manufactured for and distributed by hi-health, 15207 N. 75th Street, Suite #104, Scottsdale, AZ, 85260. NDC 77790-001-10.
Vista Tears Polyethylene Glycol 400 0.4% w/v, Propylene Glycol 0.3% w/v Eye Drops, Dry Eye Relief, Lubricant Drops, Sterile 10 ml (1/3 fl. oz.), Manufactured by: RA/Drugs/ MFG/2019/196283, Omni Lens Pvt. Ltd. 5, Samrudhhi, Opposite:Sakar-III, Navrangpura, Ahmedabad-380014, INDIA. Manufactured for and distributed by hi-health, 15207 N. 75th Street, Suite #104, Scottsdale, AZ, 85260. NDC 77790-001-10.
Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.
FDA DrugsBioGlo Fluorescein Sodium Ophthalmic Strips USP, 100 diagnostic strips, Manufactured by Omni Lens PVT. Ltd., 5 - Samrudhhi, Opp. Sakar-III, Navrangpura, Ahmedabad, Gujarat, India - 380014, Email:info@omnilens.in, Manufactured for & disibruted by: HUB Pharmaceuticals, LLC, 8767 E Via de Ventura #175, Scottsdale, AZ, 85258, NDC 17238-900-11.
BioGlo Fluorescein Sodium Ophthalmic Strips USP, 100 diagnostic strips, Manufactured by Omni Lens PVT. Ltd., 5 - Samrudhhi, Opp. Sakar-III, Navrangpura, Ahmedabad, Gujarat, India - 380014, Email:info@omnilens.in, Manufactured for & disibruted by: HUB Pharmaceuticals, LLC, 8767 E Via de Ventura #175, Scottsdale, AZ, 85258, NDC 17238-900-11.
Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.
FDA DevicesOlympus Resection Sheath, 26 Fr. with Deflecting Obturator; Model No. A22042T. Resection sheath for urologic applications.
Olympus Resection Sheath, 26 Fr. with Deflecting Obturator; Model No. A22042T. Resection sheath for urologic applications.
Complaints of the ceramic tip of the resection sheath breaking have been received.
FDA DrugsVista Gonio Eye Lubricant, Hypromellose Ophthalmic Solution USP (Sterile Drops. Dry Eye Relief, 15 ml. (1/2 fl. oz.), Wizcure Pharmaa Pvt. Ltd., H-881, Phase-3, RIICO Industrial Area, Bhiwadi-901019, INDIA, Manufactured for and distributed by: hi-health, 15207 N. 75th Street, Suite #104, Scottsdale, AZ, 85260, NDC 77790-022-15.
Vista Gonio Eye Lubricant, Hypromellose Ophthalmic Solution USP (Sterile Drops. Dry Eye Relief, 15 ml. (1/2 fl. oz.), Wizcure Pharmaa Pvt. Ltd., H-881, Phase-3, RIICO Industrial Area, Bhiwadi-901019, INDIA, Manufactured for and distributed by: hi-health, 15207 N. 75th Street, Suite #104, Scottsdale, AZ, 85260, NDC 77790-022-15.
Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.
FDA DrugsAgebox iKids-Growth (Night Formula), 60-count bottles, Manufactured Exclusively For: AGEBOX Inc., Wilmington, DE 19801 USA, UPC 850065597027
Agebox iKids-Growth (Night Formula), 60-count bottles, Manufactured Exclusively For: AGEBOX Inc., Wilmington, DE 19801 USA, UPC 850065597027
Marketed Without an Approved NDA/ANDA: presence of undeclared ibutamoren
FDA FoodMung Beans packaged in 4lb polybags; 6-4lb bags per carton
Mung Beans packaged in 4lb polybags; 6-4lb bags per carton
Presence of Thiamethoxam-PESTICIDE
FDA FoodGerber Arrowroot Biscuits, Net Wt. 5.5 oz. (155g), packaged in a plastic resealable bag with UPC 015000005962, packed 4 bags/case with UPC 015000935726; Made for Gerber Products Co., Fremont, MI 49413
Gerber Arrowroot Biscuits, Net Wt. 5.5 oz. (155g), packaged in a plastic resealable bag with UPC 015000005962, packed 4 bags/case with UPC 015000935726; Made for Gerber Products Co., Fremont, MI 49413
Downstream recall. Product contains arrowroot flour ingredient that was voluntarily recalled by the supplier due to potential contamination of soft kraft paper/plastic bag pieces.
FDA FoodTiki Bar Candy Dark Chocolatey Peanut Butter & Pretzel. Net wt: Approx: 2 oz (57g). UPC 8 55725 00514 0. Taste of Maui Snacks dba of J2C Hawaii, LLC PO Box 1023, Wailuku HI 96793. The product label is read in parts: ***INGREDIENTS: Sugar***Whey Powder, Nonfat Milk Powder, Soy Lecithin***Peanut Butter (peanuts, peanut oil***), Pretzels (wheat flour***buttermilk solids***CONTAINS MILK AND SOY ***May contain wheat, peanuts and tree nuts***"
Tiki Bar Candy Dark Chocolatey Peanut Butter & Pretzel. Net wt: Approx: 2 oz (57g). UPC 8 55725 00514 0. Taste of Maui Snacks dba of J2C Hawaii, LLC PO Box 1023, Wailuku HI 96793. The product label is read in parts: ***INGREDIENTS: Sugar***Whey Powder, Nonfat Milk Powder, Soy Lecithin***Peanut Butter (peanuts, peanut oil***), Pretzels (wheat flour***buttermilk solids***CONTAINS MILK AND SOY ***May contain wheat, peanuts and tree nuts***"
Ingredients List declares peanut but the Contains statement does not declare peanut
FDA DevicesBrand Name: Reverse Shoulder Prosthesis (RSP) Product Name: RSP STANDARD HUMERAL SOCKET INSERT, 36MM, HXe-plus Model/Catalog Number: 509-00-036
Brand Name: Reverse Shoulder Prosthesis (RSP) Product Name: RSP STANDARD HUMERAL SOCKET INSERT, 36MM, HXe-plus Model/Catalog Number: 509-00-036
Knee and Humeral socket implants contain incorrect labeling.
FDA DevicesOlympus Resection Sheath, 8 mm. Model No. A42011A. Resection sheath for gynecological applications.
Olympus Resection Sheath, 8 mm. Model No. A42011A. Resection sheath for gynecological applications.
Complaints of the ceramic tip of the resection sheath breaking have been received.
FDA DevicesMedline Sterile Saline Wound Wash, Cleansing & Wound Irrigation, USP Normal Saline (0.9% Sodium Chloride), 7.1 FL OZ (210 mL), DBD-CAN,SPRAY,7.1-OZ,SALINE,WOUND WASH,S, Model Number MDSALINE7
Medline Sterile Saline Wound Wash, Cleansing & Wound Irrigation, USP Normal Saline (0.9% Sodium Chloride), 7.1 FL OZ (210 mL), DBD-CAN,SPRAY,7.1-OZ,SALINE,WOUND WASH,S, Model Number MDSALINE7
Medline has identified that the manufacturer of the sterile saline wound wash may not have manufactured products to meet the minimum required sterility assurance level required for sterile products.
FDA DevicesOlympus Resection Sheath, 24 Fr., with Deflecting Obturator; Model No. A22041T. Resection sheath for urologic applications.
Olympus Resection Sheath, 24 Fr., with Deflecting Obturator; Model No. A22041T. Resection sheath for urologic applications.
Complaints of the ceramic tip of the resection sheath breaking have been received.
FDA DevicesConvenience kits containing Tego Connectors Medline DIALYSIS DRSNG CHNG SKU DYNDC3167
Convenience kits containing Tego Connectors Medline DIALYSIS DRSNG CHNG SKU DYNDC3167
Affected lots may exhibit issues with the silicone seal on Tego Connectors included in kits. Issues include silicone seal doming and silicone seal tearing. These issues may result in an occluded fluid path identified by the inability of the user to inject or withdraw blood product with a syringe. Damaged seals may also result in delay in therapy or fluid leakage, interruption in therapy, exposure to biological contaminants or air infused into the body.