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All product recalls affecting North Dakota.
Includes nationwide recalls (tagged “Nationwide”) and recalls with North Dakota in the distribution area.
This recall involves Kyte Baby Slumber Suits, which are one-piece sleep garments for babies. "Kyte Baby", the size, "Made in China" and care instructions are printed on the inside neck label. The recalled Slumber Suits were sold in sizes Medium (M), Large (L) and Extra Large (XL), and the colors Midnight, Taro, Slate, Sage, Blush, Cloud, Alpine Village, Crepe, Racoon, Jurassic, Eucalyptus, Blue Heron, Cloud Poppies, Haze, Midnight Poppies and Coastline.
This recall involves Tala Muse Portable Lamps with batch codes 01/21, 01/22, 01/23 and 01/24. The lithium battery-powered lamps were sold in brass, green, white, blue, red, black and pink colors and measure about 13 inches by 5 inches by 5.5 inches. The batch codes are printed on the base of the product.
cGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit
cGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit
cGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit
Surgical Patties & Surgical Strips in specific lots of Custom Convenience Kits were found to contain higher-than-expected levels of endotoxin within the raw material used to produce sterile Codman Surgical Patties and Strips that may have resulted in out-of-specification levels of endotoxin in those finished goods
Due to finished goods incorrectly packaged and labeled.
PJ Trailers is recalling certain 2024-2025 LD trailers. The air ride suspension brake axles may be installed incorrectly, resulting in reduced braking ability.
Surgical Patties & Surgical Strips in specific lots of Custom Convenience Kits were found to contain higher-than-expected levels of endotoxin within the raw material used to produce sterile Codman Surgical Patties and Strips that may have resulted in out-of-specification levels of endotoxin in those finished goods
Sumitomo Rubber USA, LLC (Sumitomo) is recalling certain Falken WildPeak AT4W size 275/60R20 115T tires. The tires may have been produced using the incorrect cord material for one of the plies. The sidewall label incorrectly identifies the generic name of the cord material. As such, the affected tires do not meet the labeling requirements of Federal Motor Vehicle Safety Standard number 139, New pneumatic radial tires for light vehicles.
BD identified through potency testing as part of a stability test request to monitor Ampicillin AM-2 due to decrease in potency results of 65% at 18 months, may result in falsely resistant result for ampicillin susceptibility
Surgical Patties & Surgical Strips in specific lots of Custom Convenience Kits were found to contain higher-than-expected levels of endotoxin within the raw material used to produce sterile Codman Surgical Patties and Strips that may have resulted in out-of-specification levels of endotoxin in those finished goods
Surgical Patties & Surgical Strips in specific lots of Custom Convenience Kits were found to contain higher-than-expected levels of endotoxin within the raw material used to produce sterile Codman Surgical Patties and Strips that may have resulted in out-of-specification levels of endotoxin in those finished goods
Marketed without an Approved NDA/ANDA: FDA analysis found product to be tainted with undeclared acetaminophen, diclofenac and phenylbutazone.
cGMP Deviations: Out of specification results for micro in hand soap products.
cGMP Deviations: Out of specification results for micro in hand soap products.
cGMP Deviations: Out of specification results for micro in hand soap products.
Winnebago Industries, Inc. (Winnebago) is recalling certain 2014-2018 Sightseer, Itasca Sunova, 2016-2025 Forza, Vista, and Itasca/Winnebago Sunstar, 2015-2025 Adventurer, 2015-2024 Commercial Vehicle, 2015-2028 Itasca Suncruiser, and 2016-2017 Itasca Solei recreational vehicles. The hood bracket adhesive may have been incorrectly applied which can allow the bracket to detach.
cGMP Deviations: Out of specification results for micro in hand soap products.
cGMP Deviations: Out of specification results for micro in hand soap products.