76 recalls · Class III, newest first
Reason Labeling: Not Elsewhere Classified: Back Label states 'Each contains: cephalexin monohydrate, USP equivalent to 5g' instead of Each Bottle…
Reason Labeling: Not Elsewhere Classified: Back label states Each contains: cephalexin monohydrate, USP equivalent to 2.5g' instead of Each Bottle…
Reason Labeling: Not Elsewhere Classified: Front label states 100 Tablets instead of 100 ml and on the back label 'Each Tablet contains' instead of…
Reason Failed Impurities/Degradation Specifications
Reason Labeling: Wrong Barcode
Reason Failed Tablet/Capsule Specifications: There is a potential for the imprint, M 122, to be missing on some tablets.
Reason Subpotent drug
Reason Failed Release Testing: Out of specification for particulate matter test.
Reason Out of specification for assay
Reason Cross Contamination with Other Products
Reason Cross Contamination with Other Products
Reason Cross Contamination with Other Products
Reason Cross Contamination with Other Products
Reason Labeling: Incorrect or missing Package Insert: There is an error on the Package Insert (PI), section 2.3, Preparation, Handling, and Administration…
Reason Labeling: Incorrect or missing Package Insert: There is an error on the Package Insert (PI), section 2.3, Preparation, Handling, and Administration…
Reason Failed dissolution specifications: out-of-specification bempedoic acid dissolution at the 0-month timepoint.
Reason Failed Impurities/Degradation Specifications
Reason Cross Contamination with Other Products:(mycophenolate mofetil).
Reason Defective Container: Out of specification for weight due to a slow leakage at the 12-month stability timepoint.
Reason Defective Container: Out of specification for weight due to a slow leakage at the 12-month stability timepoint.
Reason Failed Dissolution Specifications: results slightly under spec at at 9-months.
Reason Failed Impurities/Degradation Specifications: Out of Specification (OOS) result in the repackaged product for Related Compounds (Impurities) at the…
Reason Discoloration: discolored tablets (shades of blue) mixed in with the white inert remainder tablets.
Reason Discoloration: discolored tablets (shades of blue) mixed in with the white inert remainder tablets.
Reason Misprint on tablet