170 recalls · Class III, newest first
Labeling: Not Elsewhere Classified: Back Label states Each contains: cephalexin monohydrate, USP equivalent to 5g' on the back label instead of Each Bottle contains: cephalexin monohydrate, USP equivalent to 5g'
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
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
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.
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
Misprint on tablet
Superpotent drug: Assay results were slightly above specification at the time zero point.
Labeling: Label Mix-Up: The label of a dropper bottle mistakenly states the container is a 0.5mL single-use syringe instead of a 5 mL dropper
Sub-potent Drug: Lower potency than labeled.
Labeling: Wrong Barcode- One (1) of every forty (40) unit dose blister will contain incorrect barcode information that causes a 125mcg unit dose is scanned as 200mcg unit dose.
Failed Tablet/Capsule Specifications: Tablets were observed to have an unsmooth surface with two tablets demonstrating illegible tablet identification and scoring.
Subpotent: Out of Specification for Assay Test at the 3-month time point.
Failed Impurities/Degradation Specifications
Failed Stability Specifications