14,450 recalls · Class II, newest first
Reason Presence of foreign substance: One lot fo Metformin Hydrochloride Extended Release Tablets, USP, 500 mg (500 Count) contains foreign matter identified as a piece of rubber glove detected in one tablet.
Reason CGMP Deviations: Syringes were filled with 19mL of potassium chloride when the labels displayed a fill of 20mL.
Reason CGMP Deviations: The manufacturer of this product recalled because they were not manufactured under current good manufacturing practices.
Reason Subpotent Drug: Stability data does not support the current expiration dating of 55 days after compounding.
Reason Microbial Contamination of Sterile Products: Product associated with reports of adverse events indicative of infusion reactions related to microbiological contamination.
Reason Subpotent Drug and Failed Content Uniformity.
Reason Lack of Processing Controls: products produced in a manner that calls into question the sterility of the drug product intended to be sterile.
Reason Lack of Processing Controls: products produced in a manner that calls into question the sterility of the drug product intended to be sterile.
Reason Lack of Processing Controls: products produced in a manner that calls into question the sterility of the drug product intended to be sterile.
Reason CGMP Deviations
Reason Failed Stability Specifications: Out-of-specification for viscosity, pH and specific gravity
Reason Subpotent Drug: final drug concentration is subpotent as compared to the concentration indicated on the label.
Reason Lack of Assurance of Sterility: SCA is conducting a voluntary recall of certain lots of sterile admixtures due to a potential for leakage.
Reason Lack of Assurance of Sterility: SCA is conducting a voluntary recall of certain lots of sterile admixtures due to a potential for leakage.
Reason Lack of Assurance of Sterility: SCA is conducting a voluntary recall of certain lots of sterile admixtures due to a potential for leakage.
Reason Lack of Assurance of Sterility: SCA is conducting a voluntary recall of certain lots of sterile admixtures due to a potential for leakage.
Reason Lack of Assurance of Sterility: SCA is conducting a voluntary recall of certain lots of sterile admixtures due to a potential for leakage.
Reason Lack of Assurance of Sterility: SCA is conducting a voluntary recall of certain lots of sterile admixtures due to a potential for leakage.
Reason Lack of Assurance of Sterility: SCA is conducting a voluntary recall of certain lots of sterile admixtures due to a potential for leakage.
Reason Lack of Assurance of Sterility: SCA is conducting a voluntary recall of certain lots of sterile admixtures due to a potential for leakage.
Reason Lack of Assurance of Sterility: SCA is conducting a voluntary recall of certain lots of sterile admixtures due to a potential for leakage.
Reason Lack of Assurance of Sterility: SCA is conducting a voluntary recall of certain lots of sterile admixtures due to a potential for leakage.
Reason Lack of Assurance of Sterility: SCA is conducting a voluntary recall of certain lots of sterile admixtures due to a potential for leakage.
Reason Lack of Assurance of Sterility: SCA is conducting a voluntary recall of certain lots of sterile admixtures due to a potential for leakage.
Reason Lack of Assurance of Sterility: Potential leakage of bags.