Olanzapine Tablets, USP 2.5 mg, 30-count bottle recall — FDA D-0154-2025
Failed Impurities/Degradation Specifications
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.
Failed Impurities/Degradation Specifications
CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of the mixing vessel showed scratches on the sides and bottom of the mixing vessel. Product was…
CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of the mixing vessel showed scratches on the sides and bottom of the mixing vessel. Product was…
Superpotent Drug and Subpotent Drug: potency failures obtained
Superpotent Drug and Subpotent Drug: potency failures obtained
Subpotent and Superpotent Drug
Subpotent and Superpotent Drug
Superpotent Drug and Subpotent Drug: potency failures obtained
Subpotent and Superpotent Drug
Subpotent and Superpotent Drug
Subpotent and Superpotent Drug
CGMP Deviations: Released product should have been rejected.
Superpotent Drug and Subpotent Drug: potency failures obtained
Superpotent Drug and Subpotent Drug: potency failures obtained
Subpotent and Superpotent Drug
Superpotent Drug and Subpotent Drug: potency failures obtained
Superpotent Drug and Subpotent Drug: potency failures obtained
Superpotent Drug and Subpotent Drug: potency failures obtained
Superpotent Drug and Subpotent Drug: potency failures obtained
Defective Delivery System: incorrect silicone oil-free NormJect 10 mL Luer Lock Solo syringes packaged in the pack, instead of the required silicone oil-free NormJect 10 mL Luer Solo…
cGMP Deviations: Temperature excursion
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.
Superpotent Drug and Subpotent Drug: potency failures obtained
Superpotent Drug and Subpotent Drug: potency failures obtained
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