Prescription and over-the-counter medications
Glenmark Pharmaceuticals Inc., USA
Defective Delivery System: Estradiol Vaginal Inserts USP plunger is not functioning properly.
Failed Stability Specifications: Out of specification for viscosity.
Lack of Sterility Assurance.
Pharm D Solutions
Lack of Sterility Assurance.
Lack of Processing Controls.
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Torrent Pharma
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Pharm D Solutions
Lack of Sterility Assurance.
Pharm D Solutions
Lack of Sterility Assurance.
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Pharm D Solutions
Lack of Sterility Assurance.
Pharm D Solutions
Lack of Sterility Assurance.
Failed Impurities/Degradation Specifications: Atypical odor and unpleasant taste was reported
Lack of Sterility Assurance.
Torrent Pharma
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Baxter Healthcare
Failed Stability Specifications
Pharm D Solutions
Lack of Sterility Assurance.
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Lack of Processing Controls.
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).