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 Impurities/Degradation Specifications; out of specification for Related Compound
Reason Presence of Foreign Substance: Product complaints received for the presence of metal wire in one tablet.
Reason Failed Dissolution Specification: Out of specification for dissolution during routine stability testing.
Reason Subpotent Drug
Reason Presence of Foreign Tablet/Capsule
Reason Failed Impurities/Degradation Specifications
Reason Labeling: Label-mixup
Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Reason Out-of-specification organic impurity results obtained during routine stability testing.
Reason Failed Tablet/Capsule Specification; complaint of bulging tablet
Reason CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches.
Reason CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches.
Reason CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches.
Reason Presence of Foreign Tablets/Capsules: Lisinopril Tablets USP, 20mg found in a 1000 count bottle of Lisinopril Tablets USP, 10mg
Reason Product Mix Up: Lisinopril 10 mg tablets were found in Lisinopril 5 mg 1000-count bottle.
Reason Product Mix-Up: a complaint received indicating mix-up of 10 mg Lisinopril tablets inside of 2 sealed bottles of 20 mg/1000 count bottles.
Reason CGMP Deviations: Impurity for N-nitroso-N-methyl-4-aminobutryric Acid (NBMA) detected in active ingredient (API) used to manufacture finished…
Reason Presence of Foreign Tablet/ Capsule: Product complaint received indicating mix-up of one lisinopril 5mg tablet inside of a 30 mg, 100-count bottle of…
Reason CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable…
Reason CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable…
Reason CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to…
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