Prescription Drugs

Lack of Assurance of Sterility:Lack of validation data for sanitization cycles

Lack of Assurance of Sterility:Lack of validation data for sanitization cycles

Lack of Assurance of Sterility:Lack of validation data for sanitization cycles

Lack of Assurance of Sterility:Lack of validation data for sanitization cycles

Marketed Without an Approved NDA/ANDA: FDA analysis found the product to be tainted with sildenafil an ingredient found in a FDA approved product for the treatment of male sexual enhancement, making this an unapproved drug.

cGMP deviations: Batch was released prior to approval.

CGMP Deviations: Products not manufactured under current good manufacturing practices.

cGMP deviations: Batch was released prior to approval.

Labeling: Missing Label; customer complaint received that labels were partially or completely peeled off injection vial.

Subpotent: Out of Specification for Assay Test at the 3-month time point.

Labeling: Incorrect or Missing Lot and/or Exp Date: vials were labeled with the incorrect lot number and expiration date

Failed Impurities/Degradation Specifications

Out of Specification result observed in content uniformity testing

Labeling: Not Elsewhere Classified - the description, warnings, storage information and instructions for use are either missing or partially printed.

Lack of assurance of sterility. Validation data for decontamination cycles is lacking.

Lack of assurance of sterility. Validation data for decontamination cycles is lacking.

Lack of assurance of sterility: Lack of validation data for sanitization cycles

Failed Stability Specification and Failed Impurities/Degradation Specifications: out of specification for inactive content ascorbic acid and MTHFRC-7impurity test

Lack of assurance of sterility: Lack of validation data for sanitization cycles

Lack of assurance of sterility: Lack of validation data for sanitization cycles