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Showing 6521–6540 of 35916 results

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Infla-650 Herbal Supplement (Guru) – Undeclared Ingredients (2024)

Undeclared Allergen

Marketed without an approved NDA/ANDA: FDA analysis found product to be tainted with undeclared acetaminophen, diclofenac, and phenylbutazone.

Class IIModerate

FDAJun 26, 2024Nationwide• Guru Inc.

Sevelamer Carbonate Suspension (Dr. Reddy's) – Labeling Error (2024)

Labeling: Incorrect or Missing Lot and/or Exp Date. Missing lot number and expiration dates on packets

FDAJun 26, 2024Nationwide• Dr. Reddy's Laboratories, Inc.

DVOT SARS-CoV-2 Antigen Test (Feng Chun Yuan) – Unauthorized Sales (2024)

The "DVOT brand" rapid test kits have not obtained the necessary authorization to be sold in the United States.

FDAJun 26, 2024Nationwide• FENG CHUN YUAN MEDICAL EQUIPMENT (SHENZHEN) CO., LTD No. 1304 Science And Technology Innovation Park, Shajing Dahong Shenzhen China

Digital Analog Dental Products (Preat) – Manufacturing Rotation Issue (2024)

Due to a manufacturing issue, the product has a out of specification rotation of the digital analog used to visually inspect dental abutments and restorations.

FDAJun 25, 2024Nationwide• Preat Corp

2016 Fiat 500 (Fiat) – Tire Pressure Monitoring Issue (2024)

Chrysler (FCA US, LLC) is recalling certain 2014-2019 Fiat 500 vehicles. The tire pressure monitoring system (TPMS) warning light may not illuminate as intended. As such, these vehicles fail to comply with the requirements of Federal Motor Vehicle Safety Standard number 138, "Tire Pressure Monitoring Systems."

NHTSAJun 25, 2024Nationwide• FIAT

2024 Brinkley RV Model Z (Brinkley) – Refrigerator Power Issue (2024)

Brinkley RV (Brinkley) is recalling certain 2023-2024 Model Z fifth wheels and Model Z-Air travel trailers. The 12-volt system may have been incorrectly wired without overcurrent protection and with undersized wiring for the refrigerator, which can result in overheating.

NHTSAJun 25, 2024Nationwide• BRINKLEY RV

Sea Electric Battery Management System (Sea Electric) – Software Problem (2024)

SEA Electric LLC (SEA Electric) is recalling certain battery management system (BMS) software for electric vehicles. The BMS software can cause the high-voltage battery to shut down, resulting in a loss of drive power.

NHTSAJun 25, 2024Nationwide• SEA ELECTRIC

Miniverse Make It Mini Sets (MGA Entertainment) – Resin Hazard (2024)

This recall involves Miniverse Make It Mini Sets with unused liquid resins. These sets include "Make It Mini Appliances," all models and series of "Make It Mini Food," and "Make It Mini Lifestyle." Most sets consist of a sphere which contains the materials required to assemble the intended miniature imitation "appliance," "food," or "lifestyle" items. The resin packaging in each set may imitate food items such as a peanut butter jar, maple syrup, milk container, etc. and the resins when hardened imitate food. The sphere consists of a disposable wrapper bearing "MGA's Miniverse" on a yellow burst background and "Make It Appliances," or "Make It Mini Food," in bright pink or "Make It Mini Lifestyle" in salmon pink. The wrapper contains information related to the manufacturer's identity and country-specific information in different languages. The sets packaged in spheres could also be sold as bundles with multiple units. The "Kitchen", "Multipack", "All You Can Eat", "Ice Cream Social", and "Pizza Party" sets come in dedicated boxes with similar labeling without spheres. The item number and the UPC code are printed on the back side of the wrapper. ITEM # PRODUCT DESCRIPTION UPC BAR CODE 426028 MGA's Mini Verse PIZZA PARTY 035051426028 589938 MGA's Miniverse Food/Diner PDQ 035051589938 426011 MGA's Miniverse Make It ICE CREAM 035051426011 587200 MGA's Miniverse-Food Series Cafe PDQ 035051587200 120339 MGA's Miniverse-Make It All You Can Eat 035051120339 504153 MGA's Miniverse-Make It Mini Halloween 3pk 035051504153 593768 MGA's Miniverse-Make It Mini Hllwn PDQ 035051591768 504221 MGA's Miniverse-Make It Mini Holiday 3pk 035051504221 593782 MGA's Miniverse-Make It Mini Holiday PDQ 035051593782 591832 MGA's Miniverse-Make It Mini Kitchen 035051591832 591849 MGA's Miniverse-Make It Mini: Multi Pack 035051591849 594918 MGA's Miniverse-Make/Mini Fds Cfe 2pk 2A 035051594918 505600 MGA's Miniverse-Mini Appliances PDQ 035051505600 516507 MGA's Miniverse-Mini Birdfeeders 035051516507 505631 MGA's Miniverse-Mini Breakfast Shop 035051505631 593904 MGA's Miniverse-Mini Diner Sp/Easter 3pk 035051593904 505471 MGA's Miniverse-Mini Diner Sp/Easter PDQ 035051505471 593720 MGA's Miniverse-Mini Diner Vl Day 3pk 035051593720 505457 MGA's Miniverse-Mini Diner Vl Day PDQ 035051505457 505662 MGA's Miniverse-Mini Dinner Pack 035051505662 505419 MGA's Miniverse-Mini Food Diner S3A PDQ 035051505419 591818 MGA's Miniverse-Mini Foods Café S2A PDQ 035051591818 505396 MGA's Miniverse-Mini Foods Cafe S3A PDQ 035051505396 591825 MGA's Miniverse-Mini Foods Diner S2A PDQ 035051591825 591856 MGA's Miniverse-Mini Home S1A PDQ 035051591856 505648 MGA's Miniverse-Mini Ice Cream Shop 053505505648 505372 MGA's Miniverse-Mini Lf Home S1A PDQ 035051505372 505686 MGA's Miniverse-Mini Movie Theater S Pk 035051505686 505693 MGA's Miniverse-Mini Pastry Shop 035051505693 505655 MGA's Miniverse-Mini Sweets Shop 035051505655 505372 MGA's Miniverse-Mini Lf Home S1B PDQ 035051923749 505372 MGA's Miniverse-Mini Lf Home S1A PDQ 035051923459 505396 MGA's Miniverse-Mini Food Cafe S3B PDQ 035051923510 505396 MGA's Miniverse-Mini Foods Cafe S3A PDQ 035051923428 505419 MGA's Miniverse-Mini Food Dnr S3B PDQ 035051923527 505419 MGA's Miniverse-Mini Food Diner S3A PDQ 035051923435 505600 MGA's Miniverse-Mini Appliances PDQ 035051923442 591832 MGA's Miniverse-Make It Mini Kitchen 035051923503

CPSCJun 25, 2024Nationwide

Nature's Script CBD Roll-On (Global Widget) – Menthol Subpotency (2024)

Subpotent drug: The potency of the active (menthol) was less than the label claim of 4%.

FDAJun 25, 2024Nationwide• GLOBAL WIDGET LLC

Potassium Chloride Capsules (Amerisource) – Dissolution Failure (2024)

Failed Dissolution Specifications

FDAJun 25, 2024Nationwide• Amerisource Health Services LLC

Hemp Bombs CBD Pain Freeze (Global Widget) – Menthol Subpotency (2024)

Subpotent drug: The potency of the active (menthol) was less than the label claim of 4%.

FDAJun 25, 2024Nationwide• GLOBAL WIDGET LLC

Hemp Bombs CBD Pain Freeze (Global Widget) – Menthol Subpotency (2024)

Subpotent drug: The potency of the active (menthol) was less than the label claim of 4%.

FDAJun 25, 2024Nationwide• GLOBAL WIDGET LLC

Hemp Bombs CBD Pain Freeze (Global Widget) – Menthol Subpotency (2024)

Subpotent drug: The potency of the active (menthol) was less than the label claim of 4%.

FDAJun 25, 2024Nationwide• GLOBAL WIDGET LLC

HeartMate 3 System Controller (Thoratec) – UI Membrane Risk (2024)

Left ventricular assist system controller UI membrane/screen may lift along the edge of the controller housing, and if controller is exposed to fluid, ingress may occur, which may damage printed circuit board assemblies, which could result in unexpected and false positive alarms, loss of visual alarms, loss of user interface(use of buttons, loss of visual alarms,etc.), loss of power, and pump stop

FDAJun 25, 2024AL, AZ, AR +39 more• Thoratec LLC

Tech Medical Endo Retrieval Pouch (Unimax) – Tube Fall Risk (2024)

The tube may fall into the surgical site during the grasping process.

FDAJun 25, 2024Nationwide• UNIMAX MEDICAL SYSTEMS INC 8F-2, NO

NIM Vital Nerve Monitoring System (Medtronic) – False Negative Risk (2024)

Potential for false negative response on the NIM Vital Nerve Monitoring System

FDAJun 24, 2024Nationwide• Medtronic Xomed, Inc.

BD Pyxis MedBank Tower (CareFusion) – Label Printing Error (2024)

Due to software issue, there is a potential when a restock label is printed for a medication stored in automated dispensing cabinets, that the incorrect bin for the medication is printed on the label.

FDAJun 24, 2024Nationwide• CareFusion 303, Inc.

BD Pyxis MedBank Tower (CareFusion) – Label Printing Error (2024)

Due to software issue, there is a potential when a restock label is printed for a medication stored in automated dispensing cabinets, that the incorrect bin for the medication is printed on the label.

FDAJun 24, 2024Nationwide• CareFusion 303, Inc.

BD Pyxis MedBank Tower (CareFusion) – Label Printing Error (2024)

Due to software issue, there is a potential when a restock label is printed for a medication stored in automated dispensing cabinets, that the incorrect bin for the medication is printed on the label.

FDAJun 24, 2024Nationwide• CareFusion 303, Inc.

BD Pyxis MedBank Tower (CareFusion) – Label Printing Error (2024)

Due to software issue, there is a potential when a restock label is printed for a medication stored in automated dispensing cabinets, that the incorrect bin for the medication is printed on the label.

FDAJun 24, 2024Nationwide• CareFusion 303, Inc.

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