All Recalls

Undeclared wheat.

Contain Eggs was not listed on scale label printed at retail stores. Label does state that the product May contain any of the eight allergen that are listed out on the label,

Contain Eggs was not listed on scale label printed at retail stores. Label does state that the product May contain any of the eight allergen that are listed out on the label,

Contain Eggs was not listed on scale label printed at retail stores. Label does state that the product May contain any of the eight allergen that are listed out on the label,

Contain Eggs was not listed on scale label printed at retail stores. Label does state that the product May contain any of the eight allergen that are listed out on the label,

Contain Eggs was not listed on scale label printed at retail stores. Label does state that the product May contain any of the eight allergen that are listed out on the label,

Product is potentially contaminated with mold.

Potential elevated levels of histamine.

Contain Eggs was not listed on scale label printed at retail stores. Label does state that the product May contain any of the eight allergen that are listed out on the label,

Possible metal shavings.

CGMP deviations: Lack of potency testing.

Failed Dissolution Specifications

CGMP deviations: Lack of potency testing.

Labeling: Missing instructions for use insert

Lack of Assurance of Sterility; the media used to conduct post-compounding sterility testing for the Methotrexate product was expired.

CGMP deviations: Lack of potency testing.

CGMP deviations: Lack of potency testing.

There is potential for fractures which results in the inability to delivery therapy.

Ionized calcium test on some i-STAT CG8+ and EG7+ cartridges may exhibit higher than expected reported results when stored at room temperature (18 to 30C) for periods of time in excess of 3 days for lot numbers *20100 to *20339 and 7 days for lot numbers *20340 and above Where * = lot letter A, K, L, M, N, W or Y.

Component failures may cause the unit to lose all suction. Users will need to obtain alternate suction devices or methods, leading to a delay in treatment and, in worst case scenario, potential suffocation if alternative suction or ventilation method is not administered by the user.