Utah recalls

In some situations, the Obstruction Alarm does not trigger within the timeframe dictated by the relevant standards and may take up to four breaths.

In some situations, the Obstruction Alarm does not trigger within the timeframe dictated by the relevant standards and may take up to four breaths.

In some situations, the Obstruction Alarm does not trigger within the timeframe dictated by the relevant standards and may take up to four breaths.

In some situations, the Obstruction Alarm does not trigger within the timeframe dictated by the relevant standards and may take up to four breaths.

Potential that the "Purge System Blocked" alarm display on the Automated Impella Controller (AIC) could be delayed when using first generation Impella 5.5 (0550-0008*) pumps.

Increased risk of purge leaks with Generation 1 purge cassettes.

Product is potentially under-processed.

Product is potentially under-processed.

Products contain cyclamates (banned sweetener)

Products contain cyclamates (banned sweetener)

Products contain cyclamates (banned sweetener)

Salmonella spp. identified in finished product testing

The product states wild caught marine collagen and eggshell membrane collagen in ingredient statement but does not state EGG and the specific species of FISH parenthetically or via a Contains statement.

Packaging integrity issue that may compromise product quality .

Packaging integrity issue that may compromise product quality .

Packaging integrity issue that may compromise product quality .

Packaging integrity issue that may compromise product quality .

Product mix up: a foil pouch labeled "Magnesium Sulfate in Water for Injection, 4 g/100 mL" actually contained an IV bag of Tranexamic Acid instead.

cGMP deviation: detection of Nitrosamine Drug Substance-Related Impurities, N-nitroso-prazosin impurity C (NNP) above acceptable limits.

cGMP deviation: detection of Nitrosamine Drug Substance-Related Impurities, N-nitroso-prazosin impurity C (NNP) above acceptable limits.

cGMP deviation: detection of Nitrosamine Drug Substance-Related Impurities, N-nitroso-prazosin impurity C (NNP) above acceptable limits.

Lack of Assurance of Sterility

Lack of Assurance of Sterility

Lack of Assurance of Sterility

Lack of Assurance of Sterility

Lack of Assurance of Sterility

Lack of Assurance of Sterility

Lack of Assurance of Sterility

Lack of Assurance of Sterility

Failed Impurities/Degradation Specifications: N-nitroso-desmethyl-tramadol impurity (NDSRI) was found out of the specification at 24-month stability interval during Long term stability (25¿C/60%RH).