Class I - Dangerous
Failed Tablet/Capsule Specifications; report of oversized and discolored tablets
Qualitest Pharmaceuticals
Failed Tablet/Capsule Specifications; The identification codes on some tablets may be unreadable
Class I - Dangerous
Failed Dissolution Specifications: During routine stability testing at the 12 month time point, one product lot was found to be out of specification for dissolution.
Failed Impurities/Degradation Specifications: A stability lot was out of specification for a known impurity at the 8 month Controlled Room Temperature stability time-point.
Presence of Foriegn Substance: Plastic cap closure particulates may be present in the product.
Class I - Dangerous
Failed tablet specifications: One lot was found to contain oversized tablets.
Failed Impurities/Degradation Specifications: High out of specification results for the known impurity p-Aminophenol.
Superpotent Drug: Qualitest Pharmaceuticals is initiating a recall of three flavors of Acetaminophen Oral Suspension Liquid 160mg/5mL for failure of the product assay at the 12 month timepoint.
Superpotent Drug: Qualitest Pharmaceuticals is initiating a recall of three flavors of Acetaminophen Oral Suspension Liquid 160mg/5mL for failure of the product assay at the 12 month timepoint.
Superpotent Drug: Qualitest Pharmaceuticals is initiating a recall of three flavors of Acetaminophen Oral Suspension Liquid 160mg/5mL for failure of the product assay at the 12 month timepoint.
Subpotent; 6 month stability time point
Class I - Dangerous
Failed Tablet/Capsule Specifications: Broken tablets found in sealed bottles.
Failed impurities/degradation specifications; out of specification for the known impurity 4-chlorobenzophenone.
LABELING: Label Mix-up: 30 count Effervescent Potassium/Chloride Tablets, may be labeled as 30 count K Effervescent Tablets.
LABELING: Label Mix-up: 30 count Effervescent Potassium/Chloride Tablets, may be labeled as 30 count K Effervescent Tablets.
Class I - Dangerous
Failed Tablet/Capsule Specifications: One oversized tablet was found in a sealed 100 count bottle of Glimepiride at the retail level.