Paliperidone Extended Release Tablets 3 mg
Defective Delivery System: There is a potential for some tablets to be missing the laser drilling which might affect drug release.
982 recalls · Class II, newest first
Defective Delivery System: There is a potential for some tablets to be missing the laser drilling which might affect drug release.
CGMP Deviations: products manufactured under conditions that could impact its product quality.
CGMP Deviations: products manufactured under conditions that could impact its product quality.
CGMP Deviations: products manufactured under conditions that could impact its product quality.
CGMP Deviations: products manufactured under conditions that could impact its product quality.
CGMP Deviations: products manufactured under conditions that could impact its product quality.
CGMP Deviations: products manufactured under conditions that could impact its product quality.
Subpotent Drug: low out of specification assay results for the bacitracin zinc ingredient.
Microbial Contamination of Non-Sterile Products and Subpotent Drug: failure for microbiological growth exceeding specification and low out of specification assay results for salicylic acid.
Microbial Contamination of Non-Sterile Products: Failed microbiological testing for Staphalococcus aureus.
Superpotent Drug: high out of specification assay results for the menthol ingredient.
Subpotent Drug: low out of specification assay results for the bacitracin zinc ingredient.
Superpotent Drug: high out of specification assay results for the camphor ingredient.
Failed Stability Specifications: separation of product and failure for actives.
CGMP Deviations: products manufactured under conditions that could impact its product quality.
CGMP Deviations: products manufactured under conditions that could impact its product quality.
CGMP Deviations: products manufactured under conditions that could impact its product quality.
CGMP Deviations: products manufactured under conditions that could impact its product quality.
CGMP Deviations: products manufactured under conditions that could impact its product quality.
CGMP Deviations: products manufactured under conditions that could impact its product quality.
CGMP Deviations: products manufactured under conditions that could impact its product quality.
CGMP Deviations: products manufactured under conditions that could impact its product quality.
CGMP Deviations: products manufactured under conditions that could impact its product quality.
CGMP Deviations: products manufactured under conditions that could impact its product quality.
CGMP Deviations: products manufactured under conditions that could impact its product quality.