Microbial Contamination of Non-Sterile Product: Product is contaminated with Burkholderia gladioli.
Prescription Drugs
💊 Drugs • 12,141 recalls
Subpotent Drug
Failed Dissolution Specifications: low out-of-specification dissolution test results observed.
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
CGMP Deviations: all products within expiry are being recalled because the manufacturing firm, Teligent Pharma, Inc.is discontinuing its stability study program.
CGMP Deviations: all products within expiry are being recalled because the manufacturing firm, Teligent Pharma, Inc.is discontinuing its stability study program.
Vancomycin HCl 1.5 g in 0.9% Sodium Chloride, 500 mL bags, Rx only, SCA Pharmaceuticals Windsor, CT 06095, NDC 70004-0924-44
SCA Pharmaceuticals
CGMP Deviations
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Norepinephrine 8mg in 0.9% Sodium Chloride 250 mL bag, Rx only, SCA Pharmaceuticals Windsor, CT 06095, NDC 70004-078-40
SCA Pharmaceuticals
CGMP Deviations
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Failed viscosity specification - product was below specificcation
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
CGMP Deviations: all products within expiry are being recalled because the manufacturing firm, Teligent Pharma, Inc.is discontinuing its stability study program.
CGMP Deviations: all products within expiry are being recalled because the manufacturing firm, Teligent Pharma, Inc.is discontinuing its stability study program.
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
CGMP Deviations: all products within expiry are being recalled because the manufacturing firm, Teligent Pharma, Inc.is discontinuing its stability study program.