Metformin Hydrochloride Extended Release Tablets 1000 mg
Defective Delivery System: There is a potential for some tablets to be missing the laser drilling which might affect drug release.
Class II means the product may cause temporary or medically reversible harm, and serious harm is unlikely. It is by far the largest recall class - most potency, dissolution and labeling problems land here.
14,543 recalls, newest first.
Defective Delivery System: There is a potential for some tablets to be missing the laser drilling which might affect drug release.
Defective Delivery System: There is a potential for some tablets to be missing the laser drilling which might affect drug release.
Defective Delivery System: There is a potential for some tablets to be missing the laser drilling which might affect drug release.
Defective Delivery System: There is a potential for some tablets to be missing the laser drilling which might affect drug release.
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.