1,709 recalls · Class III, newest first
Reason Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity.
Reason Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity.
Reason Failed Stability Specifications: Out of specification test results for viscosity was identified at the 12M stability timepoint.
Reason Subpotent Drug: Low assay result observed during long-term stability testing.
Reason Short Fill: Underfilled units.
Reason Mismatching of the embossing on the tablets (T7) with the embossing mentioned in the package insert (ML63) in the distributed bottles.
Reason Failed Dissolution Specification; product did not meet the average 24-hour drug release rate (dissolution) specification stability time point at 9…
Reason Subpotent Drug: Out of specification for assay at the 18-month stability timepoint.
Reason Failed Stability Specifications: Out of specification for weight loss at the 18-month stability timepoint and projected weight loss of 21.1% at shelf…
Reason Failed Excipient Specifications: out of specification result observed for p-Hydroxybenzoic Acid content
Reason Failed dissolution specifications
Reason Subpotent drug: Out of specification for assay at the end-of-shelf-life 24-month period.
Reason Labeling: Not elsewhere classified; the product is being recalled because of customer complaints that the primary vial label was missing a barcode.
Reason Labeling: Not elsewhere classified; the product is being recalled because of customer complaints that the primary vial label was missing a barcode.
Reason Failed Impurity/Degradation Specifications
Reason Failed Impurity/Degradation Specifications
Reason Defective Delivery System: Commercial implants do not meet the filed specification for the intended use, a few patients have experienced an issue…
Reason Failed Stability Specifications
Reason Boxes mislabeled to read "Decongestant Free", but the product contains Phenylephrine HCI 5mg
Reason Presence of Particulate Matter: Piece of metal found in a vial
Reason Incorrect Product Formulation: Oxytocin 30 units was added to an IV bag of 0.45% Sodium Chloride (500mL) instead of 0.9% Sodium Chloride (500mL).
Reason Product mix-up:0.2 mg strength Clonidine Hydrochloride Tablets, USP in a 100-count bottle of 0.3 mg strength Clonidine Hydrochloride Tablets,
Reason Failed Viscosity specification: Slightly higher OOS results obtained for viscosity
Reason Failed Stability Specifications: Out of specification results reported at 12-month stability testing for aluminum content.
Reason Labeling: Not Elsewhere Classified - Incorrect label-incorrect scent listed on label.