76 recalls · Class III, newest first
Labeling: Not Elsewhere Classified: Back Label states 'Each contains: cephalexin monohydrate, USP equivalent to 5g' instead of Each Bottle contains: cephalexin monohydrate, USP equivalent to 10g'
Labeling: Not Elsewhere Classified: Back label states Each contains: cephalexin monohydrate, USP equivalent to 2.5g' instead of Each Bottle contains: cephalexin monohydrate, USP equivalent to 5g
Labeling: Not Elsewhere Classified: Front label states 100 Tablets instead of 100 ml and on the back label 'Each Tablet contains' instead of 'Each Bottle contains' No total dose per bottle listed should be 2.5 g'
Failed Impurities/Degradation Specifications
Labeling: Wrong Barcode
Failed Tablet/Capsule Specifications: There is a potential for the imprint, M 122, to be missing on some tablets.
Subpotent drug
Failed Release Testing: Out of specification for particulate matter test.
Out of specification for assay
Cross Contamination with Other Products
Cross Contamination with Other Products
Cross Contamination with Other Products
Cross Contamination with Other Products
Labeling: Incorrect or missing Package Insert: There is an error on the Package Insert (PI), section 2.3, Preparation, Handling, and Administration. The concentration of the reconstituted product is listed as '20 mg per vial.' This information should read: '20 mg per mL'.
Labeling: Incorrect or missing Package Insert: There is an error on the Package Insert (PI), section 2.3, Preparation, Handling, and Administration. The concentration of the reconstituted product is listed as '20 mg per vial.' This information should read: '20 mg per mL'.
Failed dissolution specifications: out-of-specification bempedoic acid dissolution at the 0-month timepoint.
Failed Impurities/Degradation Specifications
Cross Contamination with Other Products:(mycophenolate mofetil).
Defective Container: Out of specification for weight due to a slow leakage at the 12-month stability timepoint.
Defective Container: Out of specification for weight due to a slow leakage at the 12-month stability timepoint.
Failed Dissolution Specifications: results slightly under spec at at 9-months.
Failed Impurities/Degradation Specifications: Out of Specification (OOS) result in the repackaged product for Related Compounds (Impurities) at the 6-month time point.
Discoloration: discolored tablets (shades of blue) mixed in with the white inert remainder tablets.
Discoloration: discolored tablets (shades of blue) mixed in with the white inert remainder tablets.
Misprint on tablet