Prescription Drugs

Lack of sterility assurance

Lack of sterility assurance

Lack of sterility assurance

Failed Dissolution Specifications: This recall is being initiated in support of the recall by the manufacturer which included lots that were packaged for BluePoint Laboratories.

Failed Impurities/Degradation Specifications: High Out Of Specification degradation results.

Failed Stability Specifications: Out of specification test results for viscosity was identified at the 12M stability timepoint.

Failed Impurity (Deacetyl Diltiazem Hydrochloride) specification during stability testing and failed dissolution testing at FDA laboratory.

Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.

Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.

Failed Dissolution Specification

Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.

Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.

Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.

Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.

Presence of Foreign Substance: Presence of a small piece of green plastic embedded in the crack towards the edge of the tablet.

Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.

Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.

Short Fill: Underfilled units.

Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.

Presence of Foreign Substance: manufacturer recalled this re-packaged product due to reports of a small piece of green plastic embedded in the crack towards the edge of the tablet.