Prescription Drugs

Presence of Foreign Substance: The foreign material is primarily comprised of glass mineral wool.

Presence of Foreign Substance: The foreign material is primarily comprised of glass mineral wool.

Presence of Foreign Substance: The foreign material is primarily comprised of glass mineral wool.

Failed Impurities/Degradation Specifications

Presence of Foreign Substance: The foreign material is primarily comprised of glass mineral wool.

Incorrect Product Formulation: Hydrophilic Colloidal Silica was used to manufacture the product rather than Hydrophobic Colloidal Silica as required by the manufacturing process.

Failed Impurities/Degradation Specifications.

CGMP Deviations: Recall due to the absence of USP CGMP compendial requirements.

Failed Impurities/Degradation Specifications.

Presence of Foreign Substance: The foreign material is primarily comprised of glass mineral wool.

Presence of Foreign Substance: The foreign material is primarily comprised of glass mineral wool.

Subpotent Drug

Presence of Foreign Substance: The foreign material is primarily comprised of glass mineral wool.

Labeling: Not Elsewhere Classified

Labeling: Not Elsewhere Classified

Labeling: Not Elsewhere Classified

Failed Tablet/Capsule Specifications: Tablets were observed to have an unsmooth surface with two tablets demonstrating illegible tablet identification and scoring.

Lack of Assurance of Sterility

Lack of Assurance of Sterility

Lack of Assurance of Sterility