Neostigmine Methylsulfate Injection Solution
Labeling: Label Error on Declared Strength: syringes of Neostigmine Methylsulfate 1 mg per mL, 5 mg per 5 mL may be incorrectly labeled as Neostigmine Methylsulfate 1 mg per mL, 3 mg per 3 mL.
14,806 recalls, newest first
Labeling: Label Error on Declared Strength: syringes of Neostigmine Methylsulfate 1 mg per mL, 5 mg per 5 mL may be incorrectly labeled as Neostigmine Methylsulfate 1 mg per mL, 3 mg per 3 mL.
Labeling: Label Error on Declared Strength: syringes of Neostigmine Methylsulfate 1 mg per mL, 5 mg per 5 mL may be incorrectly labeled as Neostigmine Methylsulfate 1 mg per mL, 3 mg per 3 mL.
Microbial Contamination of Sterile Products: Product associated with reports of adverse events indicative of infusion reactions related to microbiological contamination.
Subpotent Drug and Failed Content Uniformity.
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.
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