Enalapril Maleate
Out-of-specification results for the Enalapril Diketopiperazine degradation product during commercial stability.
1,590 recalls, newest first
Out-of-specification results for the Enalapril Diketopiperazine degradation product during commercial stability.
Out-of-specification results for the Enalapril Diketopiperazine degradation product during commercial stability.
Microbial Contamination of Non-Sterile Products: The firm is initiating a recall of some of its products due to the potential of high microbial loads.
Microbial Contamination of Non-Sterile Products: The firm is initiating a recall of some of its products due to the potential of high microbial loads.
Microbial Contamination of Non-Sterile Products: The firm is initiating a recall of some of its products due to the potential of high microbial loads.
Microbial Contamination of Non-Sterile Products: The firm is initiating a recall of some of its products due to the potential of high microbial loads.
Microbial Contamination of Non-Sterile Products: The firm is initiating a recall of some of its products due to the potential of high microbial loads.
Failed Impurities/Degradation Specifications: Sub-recall because this repackaged product was recalled by the manufacturing firm, Wockhardt, due to out-of-specification results for the Enalapril DiKetopiperazine degradation product.
Failed Impurities/Degradation Specifications: Sub-recall because this repackaged product was recalled by the manufacturing firm, Wockhardt, due to out-of-specification results for the Enalapril DiKetopiperazine degradation product.
Lack of Processing Controls: products produced in a manner that calls into question the sterility of the drug product intended to be sterile.
Lack of Processing Controls: products produced in a manner that calls into question the sterility of the drug product intended to be sterile.
Lack of Processing Controls: products produced in a manner that calls into question the sterility of the drug product intended to be sterile.
Failed Impurities/Degradation Specification; out-of-specification results for the Enalapril DKT degradant
CGMP Deviations
Failed Stability Specifications: Out-of-specification for viscosity, pH and specific gravity
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
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