Microbial Contamination of Non-Sterile Products: products were found to be contaminated and above specification for lidocaine assay.
Ridge Properties
Superpotent Drug: products were found to be contaminated and above specification for lidocaine assay.
Microbial Contamination of Non-Sterile Products: products were found to be contaminated and above specification for lidocaine assay.
Superpotent Drug: products were found to be contaminated and above specification for lidocaine assay.
Superpotent Drug: products were found to be contaminated and above specification for lidocaine assay.
Superpotent Drug: products were found to be contaminated and above specification for lidocaine assay.
The packaging is not child resistant as required by the Poison Prevention Packaging Act. The pain and itch relief creams, sprays and gels contain lidocaine, posing a risk of poisoning to young children if they put it on their skin or ingest it.
GMP Deviations: inadequate manufacturing control processes
GMP Deviations: inadequate manufacturing control processes
GMP Deviations: inadequate manufacturing control processes
GMP Deviations: inadequate manufacturing control processes
GMP Deviations: inadequate manufacturing control processes