Categories
Resources
Your Recalls
Loading...
Get email alerts when new recalls match your interests.
Unapproved Drug Claims and Misbranded.
CGMP Deviations: Presence of a nitrosamine, N-nitroso-metoprolol above the established Acceptable Daily Intake (ADI) level.
Unapproved Drug Claims.
Ramen Noodle package label does not declare Soy as the source for lecithin ingredient.
Presence of foreign substance: identified as aluminum.
International Motors, LLC (International) is recalling certain 2024-2026 LT and 2025 RH trucks. The Hill Start Assist (HSA) exhaust port may become clogged, delaying or preventing the release of the service brakes.
Labeling: Label Mix-up: The outer carton is labelled Fresh Mint. The tube is labelled Cool Mint/Whitening. The toothpaste inside the tube is Fresh Mint as indicated on the outer carton
Packaging failures were identified which could lead to a breach in the sterile barrier.
Due to incomplete seals in the pouch which provide the sterile barrier.
Imported Frozen Oyster potentially contaminated with Norovirus.
Correct Labeled Product Mispack: Bags labeled for Enoxaparin Sodium Injection, 80 mg/0.8 mL, contained Enoxaparin Sodium Injection, 30 mg/0.3 mL
Potential for spoilage due to yeast contamination.
A software defect in versions 7.9.0.1 and 7.10.1 of the pump software for Tandem t:slim X2 and version 7.9.0.1 of the Tandem Mobi pump with Control-IQ+ technology that are paired with a G7 sensor may result in an unexpected automatic insulin correction bolus (autobolus ) which could result in hypoglycemia.
The Encore 26 Inflation Device is used with balloon dilation catheters to create and monitor pressure in the balloon and to deflate the balloon. An internal investigation determined that during use, foreign material particles could migrate from affected Encore 26 Inflation Devices into a balloon dilatation catheter.