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All product recalls affecting Montana.
Includes nationwide recalls (tagged “Nationwide”) and recalls with Montana in the distribution area.
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above recommended interim limit.
Presence of foreign substance: Presence of Benzene.
Failed Dissolution Specifications
Presence of foreign substance: Presence of Benzene.
Sumitomo Rubber Industries, Ltd. (Sumitomo) is recalling certain Dunlop GPR-300F tires, size 110/70R17M/C 54H. The tires may have a defect that causes inner liner bulging and looseness at the tire breaker edge. As such, these tires fail to comply with the requirements of Federal Motor Vehicle Safety Standard number 119, "New Pneumatic Tires- Other than Passenger Cars."
Chemical Contamination: This recall has been initiated due to detected trace levels of benzene.
cGMP Deviations: The recall was initiated due to detected trace levels of benzene in a specific lot of this product lot (MYX46W), however out of an abundance of caution, the firm voluntarily recalled all La Roche-Posay Effaclar Duo Dual Action Acne Treatment lots.
cGMP Deviations: The recall was initiated due to detected trace levels of benzene in a specific lot of this product lot (MYX46W), however out of an abundance of caution, the firm voluntarily recalled all La Roche-Posay Effaclar Duo Dual Action Acne Treatment lots.
The impacted lots have a higher occurrence of invalid rates when compared to the product Instructions for Use.
The impacted lots have a higher occurrence of invalid rates when compared to the product Instructions for Use.
Jayco, Inc. (Jayco) is recalling certain 2025 Jayco Eagle fifth wheels, Eagle HT fifth wheels, and Eagle HT travel trailers. The certification label states incorrect tire load and tire size information. As such, these vehicles fail to comply with the requirements of 49 CFR Part 567, "Certification."
Insulin pens may have been incorrectly assembled therefore users could experience the following: either the insulin cartridge will not fit into the cartridge holder; or the cartridge holder may be difficult to remove from the insulin pen. If the issue is present, and if the user does not have backup insulin they may experience temporary hyperglycemia.
The impacted lots have a higher occurrence of invalid rates when compared to the product Instructions for Use.
Triumph Motorcycles America, Ltd. (Triumph) is recalling certain 2025 Speed Twin 1200, Speed Twin 1200 RS, and Speed Twin 900 motorcycles. The red rear turn signals were installed too close to the rear tail light. As such, these motorcycles fail to comply with the requirements of Federal Motor Vehicle Safety Standard number 108, "Lamps, reflective devices, and associated Equipment."
There is a software issue that can permanently disable communication with an implantable neurostimulator (INS) when a specific intraoperative programming sequence is used.
AutoPulse NXT Resuscitation System may not provide adequate chest compressions or may stop compressions due to code FC1060.
Cross Contamination
Cross Contamination
Failed Dissolution Specifications: Out of specification results obtained during routine stability testing for dissolution.
CGMP Deviations: Nitrosamine Drug Substance Related Issue impurity above the daily acceptable intake limit defined by the Food and Drug Administration.