50 recalls · Class III, newest first
Reason Failed Impurities/Degradation Specifications: Out of specification result was obtained for the known impurity D.
Reason Labeling: Incorrect or Missing Lot and/or Exp Date: Potential for missing or illegible lot and expiration date coding on the bottles.
Reason Failed PH Specifications
Reason Failed Tablet/Capsule Specifications: Product complaint received that some tablets had a dent on the plain side of the tablet surface.
Reason Failed Impurities/Degradation Specifications: Due to levels of 'Diester Impurity' exceeding the specification limit.
Reason Failed Impurities/Degradation Specifications
Reason Failed Impurities/Degradation: Out of Specification results for Total Impurities and for Assay.
Reason Subpotent product:out of specification assay results observed during long term stability testing.
Reason Subpotent product:out of specification assay results observed during long term stability testing.
Reason Subpotent product:out of specification assay results observed during long term stability testing.
Reason Correct Labeled Product Mispack-Size stated on carton label did not match the size of the bottle in the carton.
Reason Cross Contamination with Other Products: Testing of reserve samples showed presence of traces of ezetimibe
Reason Cross Contamination with Other Products
Reason Sub potent drug: during the 9-month stability test conducted, the assay value for the affected lot was below specification limit.
Reason Defective Container - A defect in the side-seal which allows leakage of product.
Reason Subpotent Drug
Reason Failed Impurities/Degradation Specifications: Due to levels of 'Diester Impurity' exceeding the specification limit.
Reason Failed Impurities/Degradation Specifications: Out of specification for impurity IP-C.
Reason Failed Impurities/Degradation Specifications: Out of specification for impurity IP-C.
Reason Failed Impurities/Degradation Specifications: Out of specification for impurity IP-C.
Reason Failed Impurities/Degradation Specifications: Out of specification for impurity IP-C.
Reason Labeling: Incorrect or Missing Lot and/or Exp Date
Reason Labeling: Incorrect or Missing Lot and/or Exp Date
Reason Labeling: Incorrect or Missing Lot and/or Exp Date
Reason Labeling: Not Elsewhere Classified