💊 Drugs • 12,141 recalls
Zydus Pharmaceuticals USA
CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.
Zydus Pharmaceuticals USA
CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.
Zydus Pharmaceuticals USA
CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.
Sun Pharmaceutical Industries
Testing of Fexofenadine HCl and Pseudoephedrine Failed Impurities/Degradation Specifications: elevated substance results that were reported above or near the specification limit
Pharm D Solutions
Lack of Sterility Assurance.
Synthetopes
Lack of Processing Controls.
Pharm D Solutions
Lack of Sterility Assurance.
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Heritage Pharmaceuticals
Non-Sterility:Microbial growth detected in sub lot of Amikacin Sulfate Injection, USP 1gm/4 mL (250mg/mL) and Prochlorperazine Edisylate Injection, USP 10mg/2mL (5mg/mL) .
Torrent Pharma
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Subpotent Drug: low out-of-specification results were identified for the drug anti-factor IIa potency which is intended to ensure that the potency of heparin is within the USP specifications.
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Failed Dissolution Specifications: Out of specification result for dissolution.
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Pharm D Solutions
Lack of Sterility Assurance.
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Lack of Sterility Assurance.