MAGNESIUM CITRATE P, magnesium citrate SALINE LAXATIVE, Oral Solution, (1.745 g/fl oz) recall — FDA D-1505-2022
Microbial contamination of non-sterile products.
Browse U.S. drug recall enforcement reports from the FDA in a structured, searchable format. Review the recalled product, reason, firm, status, dates, distribution information and FDA classification when available.
10,685 detailed records are currently available in this category.
Microbial contamination of non-sterile products.
CGMP Deviations
CGMP Deviations;
Microbial contamination of non-sterile products.
Labeling: Label Error on Declared Strength; A sealed 100-count bottle labeled with 15 mg actually contained 100 tablets of 20 mg strength of the drug product.
CGMP Deviations: Product complaints reporting the product to have a gritty texture and lack of effectiveness.
Microbial contamination of non-sterile products.
Microbial contamination of non-sterile products.
Microbial contamination of non-sterile products.
CGMP Deviations
CGMP Deviations: FDA analysis found product to contain acetaldehyde impurity and the Sum of All Impurities, above specification limits.
Microbial contamination of non-sterile products.
Chemical contamination: presence of benzene
Microbial contamination of non-sterile products.
Microbial contamination of non-sterile products.
Microbial contamination of non-sterile products.
CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
cGMP Deviations: Turbidity discovered in Artificial Tears Ointment during sterility testing. Scope expanded to include other lots and products which potentially share the same root cause.
CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
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