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Prescription drugs recalled for contamination, potency or labelling.
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2,102 recalls · newest first
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Subpotent Drug- An out of specification ( OOS ) result observed in assay test during 18-month long term stability study.
LABELING: LABEL MIX-UP.
Lack of Assurance of Sterility
Defective Delivery System: incorrect silicone oil-free NormJect 10 mL Luer Lock Solo syringes packaged in the pack, instead of the required silicone…
Defective Container: patients are unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle.
Superpotent Drug
Failed Impurities/Degradation Specifications: Out-of-specification results obtained for related impurities and slightly lower than the established…
CGMP Deviations: sterile water not used for production
Lack of Assurance of Sterility
Presence of Foreign Tablets: Potential presence of Fludrocortisone Acetate Tablet USP 0.1 mg within the Methotrexate 2.5 mg 100-count Bottle.
Microbial Contamination of Sterile Products; out of limit results obtained for endotoxin testing.
Failed Dissolution Specifications: below specification results
Presence of Particulate Matter: Complaint received of a glass particle in the vial.
Presence of Particulate Matter
Defective container: unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle.
CGMP Deviations