Recalls of ARBs, ACE inhibitors, beta blockers and other hypertension drugs - the class behind the large valsartan and losartan nitrosamine recalls.
548 recalls in this category, newest first.
Reason Failed dissolution specifications: Out-of-Specification dissolution test result obtained during routine stability testing.
Reason Failed pH Specifications: Upward shift in the pH of the solution within the shelf life of the impacted lots.
Reason Subpotent Drug: One lot of product does not meet the product specification for Assay test at 3 month long term stability condition.
Reason CGMP Deviations: Detection of trace amounts of NDMA, a possible impurity or contaminant in an active pharmaceutical ingredient.
Reason Product Mix-Up: customer complaint that a sealed bottle labeled as Hydrochlorothiazide Tablets USP 12.5 mg contained only Spironolactone Tablets USP…
Reason CGMP Deviations: Detection of trace amounts of NDMA, a possible impurity or contaminant in an active pharmaceutical ingredient.
Reason CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Reason CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Reason CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Reason CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Reason CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Reason CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Reason CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Reason CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Reason CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Reason CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Reason CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Reason CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Reason CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Reason CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Reason CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Reason CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Reason CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Reason Incorrect/Undeclared Excipient: There is a potential an incorrect grade of excipient was used during manufacturing.
Reason Incorrect/Undeclared Excipient: There is a potential an incorrect grade of excipient was used during manufacturing.
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