Calcium Gluconate 10%, 100 mg/mL Injectable, Pharm D Solutions, Houston, Texas ---- NDC 69699-0914-30
Pharm D Solutions
Lack of Assurance of Sterility
💊 Drugs • 3,313 recalls
Pharm D Solutions
Lack of Assurance of Sterility
Pharm D Solutions
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Pharm D Solutions
Lack of Assurance of Sterility
Pharm D Solutions
Lack of Assurance of Sterility
Pharm D Solutions
Lack of Assurance of Sterility
Pharm D Solutions
Lack of Assurance of Sterility
Pharm D Solutions
Lack of Assurance of Sterility
Pharm D Solutions
Lack of Assurance of Sterility
Failed Impurities/Degradation Specifications:Out of specification result noticed for total impurities observed during stability analysis
CGMP Deviations: products manufactured under conditions that could impact its product quality.
Product Quest Manufacturing
CGMP Deviations: products manufactured under conditions that could impact its product quality.
Product Quest Manufacturing
CGMP Deviations: products manufactured under conditions that could impact its product quality.
Product Quest Manufacturing
Subpotent Drug: low out of specification assay results for the octocrylene and avobenzone ingredients.
Product Quest Manufacturing
CGMP Deviations: products manufactured under conditions that could impact its product quality.
Product Quest Manufacturing
CGMP Deviations: products manufactured under conditions that could impact its product quality.
Product Quest Manufacturing
CGMP Deviations: products manufactured under conditions that could impact its product quality.
Product Quest Manufacturing
Subpotent Drug: low out of specification assay results for the octocrylene and avobenzone ingredients.
Product Quest Manufacturing
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.
CGMP Deviations: products manufactured under conditions that could impact its product quality.