Prescription and over-the-counter medications
H J Harkins Company Inc
Microbial Contamination of Non-sterile Products: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
American Health Packaging
GMP Deviations; possible cross contamination of product due to cleaning procedure failure.
H J Harkins Company Inc
Microbial Contamination of Non-sterile Products: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Lack of Assurance of Sterility: FDA inspection found insufficient environmental controls, potential cross contamination and lack of product specific process validations that can result in a lack of sterility assurance.
Lack of Assurance of Sterility: FDA inspection found insufficient environmental controls, potential cross contamination and lack of product specific process validations that can result in a lack of sterility assurance.
Premier Pharmacy Labs
Lack of Assurance of Sterility: FDA inspection found insufficient environmental controls, potential cross contamination and lack of product specific process validations that can result in a lack of sterility assurance.
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
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.
cGMP Deviations: Firm was notified by their supplier of Cetirizine HCL Oral Solution, USP, 1mg/mL, 4oz, of the voluntary recall that they have initiated due to potential contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
cGMP Deviations: Firm was notified by their supplier of Cetirizine HCL Oral Solution, USP, 1mg/mL, 4oz, of the voluntary recall that they have initiated due to potential 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).
Labeling: Label mix-up: Product secondary carton erroneously states 40mg instead of 30 mg, primary carton is label correctly.
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.
Failed Impurities/Degradation Specifications
Incorrect/undeclared excipients: Hand sanitizer was made using the wrong alcohol raw material.
Zydus Pharmaceuticals USA
CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.
American Health Packaging
GMP Deviations: Potential cross contamination due to cleaning procedure failure.