Class II · Moderate risk Terminated
Irbesartan Tablets
Reason Failed Dissolution Specifications
FDA Drug Recalls
17,898 recalls, newest first
Class II · Moderate risk Terminated
Irbesartan Tablets
Reason Failed dissolution specifications.
Class II · Moderate risk Terminated
Magnesium Citrate SALINE LAXATIVE
Reason CGMP Deviations;
Class II · Moderate risk Terminated
Magnesium Citrate SALINE LAXATIVE
Reason CGMP Deviations
Class II · Moderate risk Terminated
Magnesium Citrate SALINE LAXATIVE
Reason CGMP Deviations
Class I · High risk Terminated
Walgreens
Reason Microbial contamination of non-sterile products.
Class I · High risk Terminated
Walgreens
Reason Microbial contamination of non-sterile products.
Class I · High risk Terminated
Topcare health
Reason Microbial contamination of non-sterile products.
Class I · High risk Terminated
Swan
Reason Microbial contamination of non-sterile products.
Class I · High risk Terminated
Rexall
Reason Microbial contamination of non-sterile products.
Class I · High risk Terminated
P, magnesium citrate SALINE LAXATIVE
Reason Microbial contamination of non-sterile products.
Class I · High risk Terminated
meijer
Reason Microbial contamination of non-sterile products.
Class I · High risk Terminated
Kroger
Reason Microbial contamination of non-sterile products.
Class I · High risk Terminated
EQUALINE magnesium citrate saline laxative
Reason Microbial contamination of non-sterile products.
Class I · High risk Terminated
equate Magnesium Citrate
Reason Microbial contamination of non-sterile products.
Class I · High risk Terminated
CVS Health
Reason Microbial contamination of non-sterile products.
Class II · Moderate risk Terminated
Common Sense Fragrance Free Hand Sanitizer
Reason CGMP Deviations: product manufactured using deionized water from a system lacking appropriate microbial control post deionization.
Class II · Moderate risk Terminated
Protect U Guard Foaming Hand Sanitizer
Reason CGMP Deviations: product manufactured using deionized water from a system lacking appropriate microbial control post deionization.
Class II · Moderate risk Terminated
Protect U Guard Foaming Hand Sanitizer Ophardt
Reason CGMP Deviations: product manufactured using deionized water from a system lacking appropriate microbial control post deionization.
Class II · Moderate risk Terminated
Stage 2-Ophardt Foaming Hand Sanitizer
Reason CGMP Deviations: product manufactured using deionized water from a system lacking appropriate microbial control post deionization.
Class II · Moderate risk Terminated
Avant Foaming Hand Sanitizer Ophardt
Reason CGMP Deviations: product manufactured using deionized water from a system lacking appropriate microbial control post deionization.
Class II · Moderate risk Terminated
Avant Foaming Hand Sanitizer
Reason CGMP Deviations: product manufactured using deionized water from a system lacking appropriate microbial control post deionization.
Class II · Moderate risk Terminated
Fulvestrant Injection 250mg/5mL
Reason Failed Impurities/Degradation Specifications
Class II · Moderate risk Terminated
Difluprednate Ophthalmic Emulsion
Reason Lack of Assurance of Sterility: customer complaint for defective container where breakage of the protective cap exposes tip of eye drop which could compromise sterility.
Class I · High risk Terminated
Propofol Injectable Emulsion
Reason Presence of particulate matter: particulate identified as a beetle.