Class I - Dangerous
Failed Dissolution Specifications
Upsher Smith Laboratories
Class I - Dangerous
Failed impurities/ degradation specifications: Product is Out of Specification for an unspecified degradation product.
Class I - Dangerous
Failed impurities/ degradation specifications: Product is Out of Specification for an unspecified degradation product.
Labeling: Missing Label; Three cases of product (total of 36 bottles) were packaged without the primary label on the bottle. The cases were, however, packaged in the correct finished product shipper, labeled with the correct shipper bar code label, sealed with tamper-evident tape and erroneously shipped to Upsher-Smith.
Failed Dissolution Test Requirements
Labeling: Label Error On Declared Strength; Some bottles of product were missing the color-coded strength on the primary display panel of the label.