Solco Healthcare US Valsartan and Hydrochlorothiazide
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Every FDA drug recall whose status is still Ongoing: the firm is still removing product from the market, or the FDA has not yet closed the file. Some were opened years ago and never formally terminated, so check the initiation date as well as the status.
2,760 recalls, newest first.
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Temperature Abuse: Product samples of Admelog may not have been shipped at proper temperature.
Defective Delivery System: Elevated number of units with out of specification results for leak rate
Presence of Particulate Matter: human hair found within an internal sample syringe.
Defective Delivery System: Elevated number of units with out of specification results for leak rate.
Defective Delivery System; reports of the device failing to activate which could result in a patient not receiving medication
Defective Delivery System; reports of the device failing to activate which could result in a patient not receiving medication
Microbial Contamination of Non-Sterile Products: odor complaint of product due to microbial contamination.
Subpotent Drug: Product label claim is 4% Benzoyl Peroxide, Initial Stability testing showed variation within the lot outside of product specifications.
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility