All Recalls

Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination

Presence of Particulate Matter: identified as glass and silicone material

CGMP Deviations: The manufacturer of this product recalled because they were not manufactured under current good manufacturing practices.

Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination

Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination

Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination

Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination

Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination

Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination

CGMP Deviations

Temperature Abuse: Product samples of Admelog may not have been shipped at proper temperature.

Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination

Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination

Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination

Subpotent Drug and Failed Content Uniformity.

Failed Impurities and Degradation Specifications and Subpotent Drug: out-of-specification (OOS) test results for below assay and above specification for degradants.

Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination

CGMP Deviations: Syringes were filled with 19mL of potassium chloride when the labels displayed a fill of 20mL.

Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination

Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination