557 recalls, newest first
Reason Presence of Particulate Matter: Presence of glass particle.
Reason CGMP deviations
Reason Marketed without an approved NDA/ANDA: Product found to be tainted with undeclared dexamethasone and chlorpheniramine.
Reason Microbial Contamination of a Non-sterile Product: The product was found to be contaminated with Cohnella bacteria.
Reason Lack of Assurance of Sterility: The impacted lots may contain a breach in the tube seal.
Reason Lack of Assurance of Sterility: The impacted lots may contain a breach in the tube seal.
Reason Temperature abuse: Products exposed to improper temperature above drug label specifications.
Reason cGMP Deviations: Temperature excursion
Reason Incorrect/Undeclared Excipients: The inactive ingredients labeled on the product boxes and tubes are listed as "mineral oil , petrolatum ". The…
Reason Lack of Assurance of Sterility
Reason Failed Dissolution Specifications
Reason Microbial Contamination of Non-Sterile Product
Reason Subpotent Drug
Reason Microbial contamination of non-sterile Products -
Reason Discoloration
Reason Lack of Assurance of Sterility
Reason Lack of Assurance of Sterility
Reason Lack of Assurance of Sterility
Reason Lack of Assurance of Sterility
Reason Lack of Assurance of Sterility
Reason Lack of Assurance of Sterility
Reason Lack of Assurance of Sterility
Reason Subpotent Drug- An out of specification ( OOS ) result observed in assay test during 18-month long term stability study.
Reason LABELING: LABEL MIX-UP.
Reason Lack of Assurance of Sterility