All Recalls

Lack of Assurance of Sterility; objectionable conditions observed during a FDA inspection

Lack of Assurance of Sterility; objectionable conditions observed during a FDA inspection

Labeling: Label Mix-Up: Product is incorrectly labeled as phenylephrine 50 mg in 0.9% sodium chloride rather than phenylephrine 50 mg in 5% dextrose.

Lack of Assurance of Sterility; objectionable conditions observed during a FDA inspection

Subpotent Drug; out of specification results for heparin raw material

Lack of Assurance of Sterility; objectionable conditions observed during a FDA inspection

Failed Dissolution Specifications: High out of specification dissolution result at 1 hour time point.

Lack of Assurance of Sterility; objectionable conditions observed during a FDA inspection

Lack of Assurance of Sterility; objectionable conditions observed during a FDA inspection

Lack of Assurance of Sterility; objectionable conditions observed during a FDA inspection

Labeling: incorrect or missing lot number and/or expiration date

Lack of Assurance of Sterility; objectionable conditions observed during a FDA inspection

Lack of Assurance of Sterility; objectionable conditions observed during a FDA inspection

Failed Impurities/Degradation Specifications

Lack of Assurance of Sterility; objectionable conditions observed during a FDA inspection

Failed Impurities/Degradation Specifications

Lack of Assurance of Sterility; objectionable conditions observed during a FDA inspection

Lack of Assurance of Sterility; objectionable conditions observed during a FDA inspection

Software anomaly regarding urine samples that require acidified pretreatment. The software has allowed urine samples for assays that require acidified pretreatment to be metered from the same sample container as assays that required no pretreatment when the sample was programmed.

The firm was notified that the failure of the UPS accessory devices used in conjunction with Computed Tomography X-ray systems and Diagnostic Imaging systems. may result in battery acid leakage, overheating and/or emission of fumes.