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cGMP deviations
Chemical contamination: Presence of benzene
Identified faulty cartridges. If such a faulty cartridge is used for sample testing, false test results could occur.
elevated level of lead
undeclared allergen ingredient (wheat) on product label for flour Gorditas.
Due to a software bug, automated dispensing cabinet is unable to calculate countback discrepancies during the issue process, which causes incorrect transaction quantity to be recorded. This bug can also result in the CUBIE opening more times than needed for the transaction to be completed, which may result in a patient receiving more than the intended dose of medication.
Due to a software issue, when attempting to restock the automated dispensing cabinet, user have received the banner message "Stocking window has passed, or item has been removed from purchase order. Please contact Pharmacy for assistance". When this occurs, the medication cannot be restocked and can potentially lead to delays in accessing medication for patients.
Users trying to restock a single bin location of an automated dispensing cabinet, during pocket exchange restocking workflow, may experience a software issue that results in 2 destock transactions and 2 stock transactions, which results in doubling the bin quantity, which may result in a delay in access to desired medications and/or supplies, which may lead to temporary body function impairment.
Keystone RV Company (Keystone) is recalling certain 2025 Keystone Kodiak, Colorado 260RBC, 270BHC, 280BHC, and Sunset travel trailers. The 7-way cord and 12-volt distribution box were wired incorrectly, resulting in wiring with insufficient surge protection.
Nissan North America, Inc. (Nissan) is recalling certain 2025 Sentra vehicles. The driver's seat frame may not be fully secured to the outer side of the seat track. As such, these vehicles fail to comply with the requirements of Federal Motor Vehicle Safety Standard numbers 207, "Seating Systems," and 210, "Seat Belt Assembly Anchorages."
Meyle AG (Meyle) is recalling certain control arms with part numbers 416 050 0005/S, and 416 050 0005. The control arms may fail due to a manufacturing defect.
Catheters indicated for short-or-long term access to the central venous system have tubing that exceeded melt flow index specification (higher), which could lead to increased material fatigue leaks, which could lead to infiltration, extravasation, discomfort, phlebitis, bleeding, air embolism, foreign body embolism, infection and interruption to therapy.
Incorrect software flagging may occur for the assay that may potentially lead to an erroneous result.
CGMP deviations: presence of N-Nitroso-Desmethyl Chlorpromazine impurity above the recommended interim limit.
Defective container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle
Chemical contamination: presence of benzene
Cummins Inc. (Cummins) is recalling the high voltage battery packs in certain PowerDrive 7000 electric drivetrains. Pieces of the internal fasteners in the battery may detach, causing the battery pack to short circuit and fail.
Contaminated with Listeria monocytogenes
Contains Cyclamates