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FDA DevicesMedline medical convenience kits packaged as: PEDIATRIC CATH SECUREMENT DRSG, Kit SKU DYNDC3108
Medline medical convenience kits packaged as: PEDIATRIC CATH SECUREMENT DRSG, Kit SKU DYNDC3108
Medline Industries, LP is issuing a recall for specific items and lots of Medline Kits containing BD ChloraPrep Triple Swabsticks which BD determined may exhibit an open seal on the packaging of the applicators.
FDA DrugsESTRADIOL, 22 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-3022-32.
ESTRADIOL, 22 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-3022-32.
Presence of Foreign substance - potential presence of metal particulate matter
FDA FoodKarison brand PANJIRI; NET WT. 12 oz.; Ingredients: Wheat Flour, Butter, Almonds, Sugar, Lotus Seeds, Fennel Seeds, Flax Seeds, Edible Gum, Ginger Powder, Zero Trans Fat Vegetable Shortening; UPC: 8 97307 00243 7; Distributed By: Karison Foods & Snacks Inc.; 34 Willowdale Ave., Port Washington, NY 11050; Manufactured in a facility that processes Milk, Eggs, Soybean, Tree nuts, Wheat, Peanuts and other Nuts. Product is packaged in clear plastic containers, 12-(12 oz) units/case.
Karison brand PANJIRI; NET WT. 12 oz.; Ingredients: Wheat Flour, Butter, Almonds, Sugar, Lotus Seeds, Fennel Seeds, Flax Seeds, Edible Gum, Ginger Powder, Zero Trans Fat Vegetable Shortening; UPC: 8 97307 00243 7; Distributed By: Karison Foods & Snacks Inc.; 34 Willowdale Ave., Port Washington, NY 11050; Manufactured in a facility that processes Milk, Eggs, Soybean, Tree nuts, Wheat, Peanuts and other Nuts. Product is packaged in clear plastic containers, 12-(12 oz) units/case.
Product contains milk, which is undeclared in the ingredient statement.
FDA FoodSmoked Grouper Dip 7lb plastic tub with tamper proof lid 1/7lb tub per case. Keep Refrigerated.
Smoked Grouper Dip 7lb plastic tub with tamper proof lid 1/7lb tub per case. Keep Refrigerated.
Undeclared Milk, Eggs, Sodium metabisulfite
FDA DevicesIntubation Tray (Adult) containing Suction Catheter Kits SKU DYNJAA245B
Intubation Tray (Adult) containing Suction Catheter Kits SKU DYNJAA245B
A smaller open suction catheter, the 8 Fr Suction Catheter, may have been packed within the kit instead of the required 14 Fr Suction Catheter. Use of the smaller size catheter may result in hypoxia and/or respiratory failure related to partial or full airway obstruction. Airway obstruction may require immediate emergent medical intervention to prevent respiratory failure or death. Other potential outcomes include prolonged procedure, airway irritation, or prolonged dyspnea.
FDA DrugsDoxazosin Tablets, USP, 4 mg, 1000 tablets per bottle, Rx only, distributed by Unichem Pharmaceuticals (USA), Inc., 1 Tower Center Boulevard, Suite 2200, East Brunswick, NJ 08816 USA, manufactured by Unichem Laboratories Limited, Plot Number 15 to 18, Pilerne Industrial Estate, Pilerne, Bardez, Goa (India) 403511, NDC 29300-353-10.
Doxazosin Tablets, USP, 4 mg, 1000 tablets per bottle, Rx only, distributed by Unichem Pharmaceuticals (USA), Inc., 1 Tower Center Boulevard, Suite 2200, East Brunswick, NJ 08816 USA, manufactured by Unichem Laboratories Limited, Plot Number 15 to 18, Pilerne Industrial Estate, Pilerne, Bardez, Goa (India) 403511, NDC 29300-353-10.
Tablets/Capsules Imprinted with Wrong ID
FDA DrugsESTRADIOL,15 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-3015-32.
ESTRADIOL,15 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-3015-32.
Presence of Foreign substance - potential presence of metal particulate matter
FDA FoodCarrot Top Kitchens Sundried Tomato and Caper Hummus; contains chickpeas, sundried tomatoes, tahini, capers, vinegar, salt; 8 oz.
Carrot Top Kitchens Sundried Tomato and Caper Hummus; contains chickpeas, sundried tomatoes, tahini, capers, vinegar, salt; 8 oz.
Contains undeclared sesame
FDA DevicesWB Impression Post Closed Tray incl. guide screw, L 13mm, TAN/POM
WB Impression Post Closed Tray incl. guide screw, L 13mm, TAN/POM
The mix up of the impression caps provided in the package. The provided impression caps are magenta instead of brown.
FDA FoodSpicy Breakfast Burrito in a flour tortilla. Net Weight 10 oz (283g) Scrambled eggs, Salsa, Potatoes, Jalapenos, Cheddar, Green Pepper & Onion. UPC 1 00001-00029 7. Keep Refrigerated. Manufactured By: MG Foods, Oak Creek, WI 53154.
Spicy Breakfast Burrito in a flour tortilla. Net Weight 10 oz (283g) Scrambled eggs, Salsa, Potatoes, Jalapenos, Cheddar, Green Pepper & Onion. UPC 1 00001-00029 7. Keep Refrigerated. Manufactured By: MG Foods, Oak Creek, WI 53154.
foreign material (small hard plastic fragments)
FDA DrugsTestosterone 200mg, Triamcinolone Acetonide 40mcg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-6200-43.
Testosterone 200mg, Triamcinolone Acetonide 40mcg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-6200-43.
Presence of Foreign substance - potential presence of metal particulate matter
FDA DevicesIQon Spectral CT; Product Code (REF): 728332;
IQon Spectral CT; Product Code (REF): 728332;
As part of the CT systems sub assembly, thirty-two (32) fasteners are used to attach the rotor to the bearing within the gantry. One or more of these fasteners may not be torqued to specification. If multiple fasteners are not torqued to specification, the rotor or rotor parts may become unsecured or displaced. While there has been no reported or observed event of expelled parts during gantry rotation, unsecured rotor parts may potentially be expelled.
FDA DrugsTestosterone, 200 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-1200-43.
Testosterone, 200 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-1200-43.
Presence of Foreign substance - potential presence of metal particulate matter
FDA DevicesMedline medical convenience kits packaged as: 1) POWERGLIDE DRESSING CHANGE KIT, Kit SKU DYNDH1576; 2) CENTRAL LINE TRAY W/ CHLRP SWB, Kit SKU RWM-DC57KC.
Medline medical convenience kits packaged as: 1) POWERGLIDE DRESSING CHANGE KIT, Kit SKU DYNDH1576; 2) CENTRAL LINE TRAY W/ CHLRP SWB, Kit SKU RWM-DC57KC.
Medline Industries, LP is issuing a recall for specific items and lots of Medline Kits containing BD ChloraPrep Triple Swabsticks which BD determined may exhibit an open seal on the packaging of the applicators.
FDA DrugsTestosterone, 50.0 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-1050-32.
Testosterone, 50.0 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-1050-32.
Presence of Foreign substance - potential presence of metal particulate matter
FDA FoodBrand: Red Button Movie House Popcorn Pack Size: 24 oz. / 680g. SKU/UPC:4117281332 Shelf life: 150 days. Packaging: Plastic bag Production location: Lee s Commissary 888 W 1600 S Unit 130, Logan Ut. 84321 Distributed by: Associated Food Stores
Brand: Red Button Movie House Popcorn Pack Size: 24 oz. / 680g. SKU/UPC:4117281332 Shelf life: 150 days. Packaging: Plastic bag Production location: Lee s Commissary 888 W 1600 S Unit 130, Logan Ut. 84321 Distributed by: Associated Food Stores
Product may contain foreign material.
FDA DrugsTestosterone, 37.5 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-1037-32.
Testosterone, 37.5 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-1037-32.
Presence of Foreign substance - potential presence of metal particulate matter
FDA DevicesAzurion 5 M12 System Model Numbers: (1)722227, (2)722231; Software Version Number - All versions: R1.X, R2.X, R3.X
Azurion 5 M12 System Model Numbers: (1)722227, (2)722231; Software Version Number - All versions: R1.X, R2.X, R3.X
Under certain conditions, the table may move unexpectedly when the Reset Geometry button is pressed - even when a table lock is active.
FDA DrugsTestosterone, 25.0 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-1025-32.
Testosterone, 25.0 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-1025-32.
Presence of Foreign substance - potential presence of metal particulate matter
FDA DevicesAzurion 7 B20 System Model Numbers: (1)722068, (2)722226, (3)722236; Software Version Number - All versions: R1.X, R2.X, R3.X
Azurion 7 B20 System Model Numbers: (1)722068, (2)722226, (3)722236; Software Version Number - All versions: R1.X, R2.X, R3.X
Under certain conditions, the table may move unexpectedly when the Reset Geometry button is pressed - even when a table lock is active.
Germany BVLStretcherz vierer Pack
Stretcherz vierer Pack
Gesundheitsschädliche Substanz
FDA DrugsTestosterone 100mg, Anastrozole 4mg (4.5), 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-4104-01.
Testosterone 100mg, Anastrozole 4mg (4.5), 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-4104-01.
Presence of Foreign substance - potential presence of metal particulate matter
FDA DrugsESTRADIOL, 25 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-3025-32.
ESTRADIOL, 25 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-3025-32.
Presence of Foreign substance - potential presence of metal particulate matter
FDA DrugsUDENYCA, pegfilgrastim-cbqv injection, 6 mg/0.6mL Single Dose Prefilled Syringe, Rx only, Manufactured by Accord BioPharma, Inc., 8041 Arco Corporate Drive, Suite 200, Raleigh, NC 27617, NDC 69448-025-63
UDENYCA, pegfilgrastim-cbqv injection, 6 mg/0.6mL Single Dose Prefilled Syringe, Rx only, Manufactured by Accord BioPharma, Inc., 8041 Arco Corporate Drive, Suite 200, Raleigh, NC 27617, NDC 69448-025-63
Temperature Abuse. 116 cartons with specific serial numbers of Lot 2199821, were stored incorrectly in a controlled room temperature environment instead of the required refrigerated environment.