Todd Holiday dba Sunstone Organics Maeng Da Kratom recall — FDA D-0986-2019
MICROBIAL CONTAMINATION OF NON-STERILE PRODUCTS: Analysis of samples were positive for Salmonella.
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MICROBIAL CONTAMINATION OF NON-STERILE PRODUCTS: Analysis of samples were positive for Salmonella.
Failed Dissolution Specifications: High Out-of-Specification dissolution results were observed during stability testing.
MICROBIAL CONTAMINATION OF NON-STERILE PRODUCTS: Analysis of samples were positive for Salmonella.
Does Not Meet Monograph: product contains, triclosan, an ingredient that can no longer be contained in over-the-counter consumer antiseptic/antibacterial wash products.
MICROBIAL CONTAMINATION OF NON-STERILE PRODUCTS: Analysis of samples were positive for Salmonella.
Incorrect Product Formulation; compounded sterile drug reconstituted using sterile water instead of sterile 0.9% Sodium Chloride.
MICROBIAL CONTAMINATION OF NON-STERILE PRODUCTS: Analysis of samples were positive for Salmonella.
Cross Contamination: Presence of IPA in finished product.
Failed Dissolution Specifications; 9-monthstability timepoint
General Motors LLC (GM) is recalling certain Chevrolet Equinox and GMC Terrain vehicles. The rear-right seat may have insufficient welds on the head-restraint bracket.
Possible cracks on the body of the fill port connector, which may result in a leak. If the leak is identified while the user is filling the pump, there may be a delay while an alternative…
Possible cracks on the body of the fill port connector, which may result in a leak. If the leak is identified while the user is filling the pump, there may be a delay while an alternative…
Possible cracks on the body of the fill port connector, which may result in a leak. If the leak is identified while the user is filling the pump, there may be a delay while an alternative…
Vanguard Knee System Series-A Standard Patella a potential commingle that could result in the size of the implant not matching the size on the label.
Certain configurations of Merge Eye Station hardware may result in electrical output that exceeds the allowable limits for medical devices. Leakage current was found to exceed allowable…
Panels inoculated using certain lots of the indicator solution are demonstrating an increased occurrence of test aborts.
This notice has been initiated due to potential for compromised test card Top Seal Integrity which could: - yield false resistance for antibiotics on the AST panel - cause a false negative…
Possible cracks on the body of the fill port connector, which may result in a leak. If the leak is identified while the user is filling the pump, there may be a delay while an alternative…
Panels inoculated using certain lots of the indicator solution are demonstrating an increased occurrence of test aborts.
There is a potential for one lot of ChemoLock Vial Spike to contain burr particulate
Certain LIFEPAK 15 Monitors/ Defibrillators were reported to experience a lockup condition after a shock was delivered. This condition is defined as a blank monitor display with LED lights…
A software error may result in a system crash. The system must be restarted before the clinical procedure can be continued. The ablation treatment must be performed with a different system…
Panels inoculated using certain lots of the indicator solution are demonstrating an increased occurrence of test aborts.
The Vitality Shear-off Set Screw is not threading properly with the mating tulip head of the Vitality screws, hooks and connectors due to a manufacturing issue.These devices are indicated…
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