Prescription Drugs

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.

GMP Deviations; possible cross contamination of product due to cleaning procedure failure.

GMP Deviations; possible cross contamination of product due to cleaning procedure failure.

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.

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.

Testing of Fexofenadine HCl and Pseudoephedrine Failed Impurities/Degradation Specifications: elevated substance results that were reported above or near the specification limit

CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.

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).

Labeling: Label mix-up: Product secondary carton erroneously states 40mg instead of 30 mg, primary carton is label correctly.

CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.

CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.

CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.

Failed Impurities/Degradation Specifications

CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.

GMP Deviations: Potential cross contamination due to cleaning procedure failure.

CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.

CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.